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CystoFlex™ R N

Model FP-10032 · MAUNA KEA TECHNOLOGIES · DI 03760187912042

OWN — Confocal Optical Imaging · Class II · 21 CFR 876.1500

UDILibrary device dossier · generated 2026-09-06 · 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.

61117222019-01: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 2/device2019-06: 0 reports for this device; peer average 1.67/device2019-07: 0 reports for this device; peer average 1.5/device2019-08: 0 reports for this device; peer average 1.5/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 2.75/device2019-11: 0 reports for this device; peer average 2.5/device2019-12: 0 reports for this device; peer average 5/device2020-01: 0 reports for this device; peer average 1.67/device2020-02: 0 reports for this device; peer average 2.5/device2020-03: 0 reports for this device; peer average 1.67/device2020-04: 0 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 1.5/device2020-06: 0 reports for this device; peer average 4/device2020-07: 0 reports for this device; peer average 2.17/device2020-08: 0 reports for this device; peer average 2.2/device2020-09: 0 reports for this device; peer average 2.6/device2020-10: 0 reports for this device; peer average 3.33/device2020-11: 0 reports for this device; peer average 2/device2020-12: 0 reports for this device; peer average 2.33/device2021-01: 0 reports for this device; peer average 3.4/device2021-02: 0 reports for this device; peer average 2/device2021-03: 0 reports for this device; peer average 3.43/device2021-04: 0 reports for this device; peer average 5.4/device2021-05: 0 reports for this device; peer average 2.88/device2021-06: 0 reports for this device; peer average 2.88/device2021-07: 0 reports for this device; peer average 3.29/device2021-08: 0 reports for this device; peer average 3.38/device2021-09: 0 reports for this device; peer average 4.25/device2021-10: 0 reports for this device; peer average 3/device2021-11: 0 reports for this device; peer average 3.29/device2021-12: 0 reports for this device; peer average 6/device2022-01: 0 reports for this device; peer average 3.71/device2022-02: 0 reports for this device; peer average 8.4/device2022-03: 0 reports for this device; peer average 6.33/device2022-04: 0 reports for this device; peer average 5.83/device2022-05: 0 reports for this device; peer average 12.63/device2022-06: 0 reports for this device; peer average 10.83/device2022-07: 0 reports for this device; peer average 5.57/device2022-08: 0 reports for this device; peer average 4.4/device2022-09: 0 reports for this device; peer average 3.9/device2022-10: 0 reports for this device; peer average 4.38/device2022-11: 0 reports for this device; peer average 5.9/device2022-12: 0 reports for this device; peer average 4.75/device2023-01: 0 reports for this device; peer average 5.29/device2023-02: 0 reports for this device; peer average 4.63/device2023-03: 0 reports for this device; peer average 6.27/device2023-04: 0 reports for this device; peer average 7.25/device2023-05: 0 reports for this device; peer average 7.75/device2023-06: 0 reports for this device; peer average 4.7/device2023-07: 0 reports for this device; peer average 6.75/device2023-08: 0 reports for this device; peer average 8/device2023-09: 0 reports for this device; peer average 10.14/device2023-10: 0 reports for this device; peer average 7.44/device2023-11: 0 reports for this device; peer average 8.22/device2023-12: 0 reports for this device; peer average 8.88/device2024-01: 0 reports for this device; peer average 7.91/device2024-02: 0 reports for this device; peer average 15.86/device2024-03: 0 reports for this device; peer average 14/device2024-04: 0 reports for this device; peer average 11.11/device2024-05: 0 reports for this device; peer average 11.71/device2024-06: 0 reports for this device; peer average 18.83/device2024-07: 0 reports for this device; peer average 22.4/device2024-08: 0 reports for this device; peer average 13/device2024-09: 0 reports for this device; peer average 12.86/device2024-10: 0 reports for this device; peer average 13.71/device2024-11: 0 reports for this device; peer average 6.25/device2024-12: 0 reports for this device; peer average 9.67/device2025-01: 0 reports for this device; peer average 8/device2025-02: 0 reports for this device; peer average 3.63/device2025-03: 0 reports for this device; peer average 5.5/device2025-04: 0 reports for this device; peer average 4.33/device2025-05: 0 reports for this device; peer average 4.4/device2025-06: 0 reports for this device; peer average 5/device2025-07: 0 reports for this device; peer average 6.88/device2025-08: 0 reports for this device; peer average 4.8/device2025-09: 0 reports for this device; peer average 3.83/device2025-10: 0 reports for this device; peer average 4.23/device2025-11: 0 reports for this device; peer average 3.71/device2025-12: 0 reports for this device; peer average 4.79/device2026-01: 0 reports for this device; peer average 4.9/device2026-02: 0 reports for this device; peer average 3.5/device2026-03: 0 reports for this device; peer average 4/device2026-04: 0 reports for this device; peer average 6.21/device2026-05: 0 reports for this device; peer average 4.2/device2026-06: 0 reports for this device; peer average 3.87/device0103040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0301
2019-0402
2019-0502
2019-0601.67
2019-0701.5
2019-0801.5
2019-0901
2019-1002.75
2019-1102.5
2019-1205
2020-0101.67
2020-0202.5
2020-0301.67
2020-0401
2020-0501.5
2020-0604
2020-0702.17
2020-0802.2
2020-0902.6
2020-1003.33
2020-1102
2020-1202.33
2021-0103.4
2021-0202
2021-0303.43
2021-0405.4
2021-0502.88
2021-0602.88
2021-0703.29
2021-0803.38
2021-0904.25
2021-1003
2021-1103.29
2021-1206
2022-0103.71
2022-0208.4
2022-0306.33
2022-0405.83
2022-05012.63
2022-06010.83
2022-0705.57
2022-0804.4
2022-0903.9
2022-1004.38
2022-1105.9
2022-1204.75
2023-0105.29
2023-0204.63
2023-0306.27
2023-0407.25
2023-0507.75
2023-0604.7
2023-0706.75
2023-0808
2023-09010.14
2023-1007.44
2023-1108.22
2023-1208.88
2024-0107.91
2024-02015.86
2024-03014
2024-04011.11
2024-05011.71
2024-06018.83
2024-07022.4
2024-08013
2024-09012.86
2024-10013.71
2024-1106.25
2024-1209.67
2025-0108
2025-0203.63
2025-0305.5
2025-0404.33
2025-0504.4
2025-0605
2025-0706.88
2025-0804.8
2025-0903.83
2025-1004.23
2025-1103.71
2025-1204.79
2026-0104.9
2026-0203.5
2026-0304
2026-0406.21
2026-0504.2
2026-0603.87
This device (reports/month)Average device in OWN (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K193416 — cites (transitively): K172844 (d1), K183640 (d1), K111047 (d2), K122042 (d2), K123676 (d2), K133466 (d2), K150831 (d2), K151593 (d2), K160416 (d2), K171345 (d2), K051585 (d3), K061666 (d3), K050403 (d3), K052194 (d3), K120208 (d3), K092359 (d3), K123673 (d3), K132389 (d3), K141358 (d3), K013165 (d3), K011496 (d4), K043022 (d4), K091962 (d4) — cited as predicate by K212322

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

Manufacturer compliance record — MAUNA KEA TECHNOLOGIES

  • NAI 2024-07-04 Mauna Kea Technologies · 0 citations
  • NAI 2024-07-04 Mauna Kea Technologies · 0 citations
  • VAI 2018-05-17 Mauna Kea Technologies · 0 citations
  • VAI 2018-05-17 Mauna Kea Technologies · 0 citations
  • VAI 2014-01-30 Mauna Kea Technologies · 2 citations
  • VAI 2014-01-30 Mauna Kea Technologies · 2 citations