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Coupling piece 5mm

Model 077.0161 · Medela AG · DI 07612367021906

BTA — Pump, Portable, Aspiration (Manual Or Powered) · Class II · 21 CFR 878.4780

HDB — Extractor, Vacuum, Fetal · Class II · 21 CFR 884.4340

MUU — System, Suction, Lipoplasty · Class II · 21 CFR 878.5040

QPB — System, Suction, Lipoplasty For Removal · Class II · 21 CFR 878.5040

UDILibrary device dossier · generated 2026-09-12 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

4913182019-01: 0 reports for this device; peer average 1.67/device2019-02: 0 reports for this device; peer average 2.3/device2019-03: 0 reports for this device; peer average 1.57/device2019-04: 0 reports for this device; peer average 1.71/device2019-05: 0 reports for this device; peer average 1.67/device2019-06: 0 reports for this device; peer average 2.2/device2019-07: 0 reports for this device; peer average 2.33/device2019-08: 0 reports for this device; peer average 2/device2019-09: 0 reports for this device; peer average 1.75/device2019-10: 0 reports for this device; peer average 2.2/device2019-11: 0 reports for this device; peer average 5.71/device2019-12: 0 reports for this device; peer average 1.5/device2020-01: 0 reports for this device; peer average 2.75/device2020-02: 0 reports for this device; peer average 1.13/device2020-03: 0 reports for this device; peer average 1.83/device2020-04: 0 reports for this device; peer average 2.8/device2020-05: 0 reports for this device; peer average 2.33/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 2/device2020-08: 0 reports for this device; peer average 1.6/device2020-09: 0 reports for this device; peer average 3/device2020-10: 0 reports for this device; peer average 2.5/device2020-11: 0 reports for this device; peer average 2.33/device2020-12: 0 reports for this device; peer average 2/device2021-01: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 4/device2021-03: 0 reports for this device; peer average 2.5/device2021-04: 0 reports for this device; peer average 2.4/device2021-05: 0 reports for this device; peer average 3/device2021-06: 0 reports for this device; peer average 3/device2021-07: 0 reports for this device; peer average 3.2/device2021-08: 0 reports for this device; peer average 8.83/device2021-09: 0 reports for this device; peer average 13.25/device2021-10: 0 reports for this device; peer average 13.33/device2021-11: 0 reports for this device; peer average 6/device2021-12: 0 reports for this device; peer average 6.6/device2022-01: 0 reports for this device; peer average 4.67/device2022-02: 0 reports for this device; peer average 4.5/device2022-03: 0 reports for this device; peer average 12/device2022-04: 0 reports for this device; peer average 10.2/device2022-05: 0 reports for this device; peer average 3.17/device2022-06: 0 reports for this device; peer average 3.2/device2022-07: 0 reports for this device; peer average 2.36/device2022-08: 0 reports for this device; peer average 4.11/device2022-09: 0 reports for this device; peer average 6.4/device2022-10: 0 reports for this device; peer average 3.56/device2022-11: 0 reports for this device; peer average 8.17/device2022-12: 0 reports for this device; peer average 4.2/device2023-01: 0 reports for this device; peer average 9.57/device2023-02: 0 reports for this device; peer average 17.75/device2023-03: 0 reports for this device; peer average 11.85/device2023-04: 0 reports for this device; peer average 12.33/device2023-05: 0 reports for this device; peer average 12.83/device2023-06: 0 reports for this device; peer average 8.56/device2023-07: 0 reports for this device; peer average 7/device2023-08: 0 reports for this device; peer average 10.63/device2023-09: 0 reports for this device; peer average 7/device2023-10: 0 reports for this device; peer average 9.75/device2023-11: 0 reports for this device; peer average 10.67/device2023-12: 0 reports for this device; peer average 4.3/device2024-01: 0 reports for this device; peer average 5.44/device2024-02: 0 reports for this device; peer average 14.88/device2024-03: 0 reports for this device; peer average 6.64/device2024-04: 0 reports for this device; peer average 8.44/device2024-05: 0 reports for this device; peer average 13.25/device2024-06: 0 reports for this device; peer average 6.5/device2024-07: 0 reports for this device; peer average 10/device2024-08: 0 reports for this device; peer average 7/device2024-09: 0 reports for this device; peer average 12.4/device2024-10: 0 reports for this device; peer average 12.71/device2024-11: 0 reports for this device; peer average 9/device2024-12: 0 reports for this device; peer average 6.25/device2025-01: 0 reports for this device; peer average 6.44/device2025-02: 0 reports for this device; peer average 3.25/device2025-03: 0 reports for this device; peer average 6.5/device2025-04: 0 reports for this device; peer average 6/device2025-05: 0 reports for this device; peer average 5.42/device2025-06: 0 reports for this device; peer average 6.63/device2025-07: 0 reports for this device; peer average 12/device2025-08: 0 reports for this device; peer average 5.56/device2025-09: 0 reports for this device; peer average 3.57/device2025-10: 0 reports for this device; peer average 4.88/device2025-11: 0 reports for this device; peer average 6/device2025-12: 0 reports for this device; peer average 7.6/device2026-01: 0 reports for this device; peer average 4.25/device2026-02: 0 reports for this device; peer average 3.75/device2026-03: 0 reports for this device; peer average 8.75/device2026-04: 0 reports for this device; peer average 8.63/device2026-05: 0 reports for this device; peer average 6.5/device2026-06: 0 reports for this device; peer average 5.09/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.67
2019-0202.3
2019-0301.57
2019-0401.71
2019-0501.67
2019-0602.2
2019-0702.33
2019-0802
2019-0901.75
2019-1002.2
2019-1105.71
2019-1201.5
2020-0102.75
2020-0201.13
2020-0301.83
2020-0402.8
2020-0502.33
2020-0602
2020-0702
2020-0801.6
2020-0903
2020-1002.5
2020-1102.33
2020-1202
2021-0101
2021-0204
2021-0302.5
2021-0402.4
2021-0503
2021-0603
2021-0703.2
2021-0808.83
2021-09013.25
2021-10013.33
2021-1106
2021-1206.6
2022-0104.67
2022-0204.5
2022-03012
2022-04010.2
2022-0503.17
2022-0603.2
2022-0702.36
2022-0804.11
2022-0906.4
2022-1003.56
2022-1108.17
2022-1204.2
2023-0109.57
2023-02017.75
2023-03011.85
2023-04012.33
2023-05012.83
2023-0608.56
2023-0707
2023-08010.63
2023-0907
2023-1009.75
2023-11010.67
2023-1204.3
2024-0105.44
2024-02014.88
2024-0306.64
2024-0408.44
2024-05013.25
2024-0606.5
2024-07010
2024-0807
2024-09012.4
2024-10012.71
2024-1109
2024-1206.25
2025-0106.44
2025-0203.25
2025-0306.5
2025-0406
2025-0505.42
2025-0606.63
2025-07012
2025-0805.56
2025-0903.57
2025-1004.88
2025-1106
2025-1207.6
2026-0104.25
2026-0203.75
2026-0308.75
2026-0408.63
2026-0506.5
2026-0605.09
This device (reports/month)Average device in BTA, HDB, MUU, QPB (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K130123 — cites (transitively): K011725 (d1), K021368 (d1) — cited as predicate by K150134, K170329, K260892

K150134 — cites (transitively): K032802 (d1), K051749 (d1), K063336 (d1), K130123 (d1), K011725 (d2), K021368 (d2) — cited as predicate by K160950, K170329

K153663 — cites (transitively): K061205 (d1), K061435 (d1) — cited as predicate by K153633, K221676

K170329 — cites (transitively): K051758 (d1), K130123 (d1), K150134 (d1), K011725 (d2), K021368 (d2), K032802 (d2), K051749 (d2), K063336 (d2) — cited as predicate by K173841, K183464

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — Medela AG

  • Warning Letter 2011-02-25 Medela Inc
  • Warning Letter 2011-02-25 Medela Inc
  • NAI 2014-08-27 Medela Inc · 0 citations
  • NAI 2014-08-27 Medela Inc · 0 citations
  • NAI 2014-02-26 Medela Inc · 0 citations
  • NAI 2014-02-26 Medela Inc · 0 citations
  • OAI 2012-05-25 Medela Inc · 7 citations
  • OAI 2012-05-25 Medela Inc · 7 citations
  • NAI 2011-11-21 Medela Inc · 0 citations
  • NAI 2011-11-21 Medela Inc · 0 citations
  • VAI 2011-08-09 Medela Inc · 0 citations
  • VAI 2011-08-09 Medela Inc · 0 citations
  • OAI 2010-11-01 Medela Inc · 0 citations
  • OAI 2010-11-01 Medela Inc · 0 citations
  • VAI 2010-01-21 Medela Inc · 7 citations
  • VAI 2010-01-21 Medela Inc · 7 citations