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Bullet Tip Adapter Package

Model RED-NTA-03 · Surgentec, LLC · DI 00810131881320

FMF — Syringe, Piston · Class II · 21 CFR 880.5860

UDILibrary device dossier · generated 2026-09-13 · 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 2.92/device2019-02: 0 reports for this device; peer average 3.83/device2019-03: 0 reports for this device; peer average 3.38/device2019-04: 0 reports for this device; peer average 3.19/device2019-05: 0 reports for this device; peer average 4/device2019-06: 0 reports for this device; peer average 3.22/device2019-07: 0 reports for this device; peer average 3.63/device2019-08: 0 reports for this device; peer average 4.08/device2019-09: 0 reports for this device; peer average 4.22/device2019-10: 0 reports for this device; peer average 3.43/device2019-11: 0 reports for this device; peer average 3.02/device2019-12: 0 reports for this device; peer average 2.8/device2020-01: 0 reports for this device; peer average 3.15/device2020-02: 0 reports for this device; peer average 3.53/device2020-03: 0 reports for this device; peer average 2.95/device2020-04: 0 reports for this device; peer average 3.45/device2020-05: 0 reports for this device; peer average 3.28/device2020-06: 0 reports for this device; peer average 2.64/device2020-07: 0 reports for this device; peer average 3.24/device2020-08: 0 reports for this device; peer average 3.24/device2020-09: 0 reports for this device; peer average 4.05/device2020-10: 0 reports for this device; peer average 3.82/device2020-11: 0 reports for this device; peer average 3.28/device2020-12: 0 reports for this device; peer average 3.2/device2021-01: 0 reports for this device; peer average 2.43/device2021-02: 0 reports for this device; peer average 3.32/device2021-03: 0 reports for this device; peer average 2.96/device2021-04: 0 reports for this device; peer average 3.05/device2021-05: 0 reports for this device; peer average 2.16/device2021-06: 0 reports for this device; peer average 2.31/device2021-07: 0 reports for this device; peer average 3.09/device2021-08: 0 reports for this device; peer average 3.13/device2021-09: 0 reports for this device; peer average 3.57/device2021-10: 0 reports for this device; peer average 2.55/device2021-11: 0 reports for this device; peer average 2.37/device2021-12: 0 reports for this device; peer average 2.31/device2022-01: 0 reports for this device; peer average 2.27/device2022-02: 0 reports for this device; peer average 2.81/device2022-03: 0 reports for this device; peer average 2.62/device2022-04: 0 reports for this device; peer average 2.31/device2022-05: 0 reports for this device; peer average 2.47/device2022-06: 0 reports for this device; peer average 2.58/device2022-07: 0 reports for this device; peer average 2.56/device2022-08: 0 reports for this device; peer average 2.65/device2022-09: 0 reports for this device; peer average 2.55/device2022-10: 0 reports for this device; peer average 2.69/device2022-11: 0 reports for this device; peer average 4.2/device2022-12: 0 reports for this device; peer average 3.19/device2023-01: 0 reports for this device; peer average 4.29/device2023-02: 0 reports for this device; peer average 4.73/device2023-03: 0 reports for this device; peer average 5.6/device2023-04: 0 reports for this device; peer average 4.98/device2023-05: 0 reports for this device; peer average 5/device2023-06: 0 reports for this device; peer average 5.14/device2023-07: 0 reports for this device; peer average 6.02/device2023-08: 0 reports for this device; peer average 5.7/device2023-09: 0 reports for this device; peer average 5.14/device2023-10: 0 reports for this device; peer average 4.48/device2023-11: 0 reports for this device; peer average 3.85/device2023-12: 0 reports for this device; peer average 5.61/device2024-01: 0 reports for this device; peer average 4.24/device2024-02: 0 reports for this device; peer average 7.28/device2024-03: 0 reports for this device; peer average 8.65/device2024-04: 0 reports for this device; peer average 13.36/device2024-05: 0 reports for this device; peer average 17.87/device2024-06: 0 reports for this device; peer average 16.58/device2024-07: 0 reports for this device; peer average 13.72/device2024-08: 0 reports for this device; peer average 9.31/device2024-09: 0 reports for this device; peer average 7.24/device2024-10: 0 reports for this device; peer average 5.47/device2024-11: 0 reports for this device; peer average 3.94/device2024-12: 0 reports for this device; peer average 4.21/device2025-01: 0 reports for this device; peer average 2.94/device2025-02: 0 reports for this device; peer average 2.37/device2025-03: 0 reports for this device; peer average 2.97/device2025-04: 0 reports for this device; peer average 3.33/device2025-05: 0 reports for this device; peer average 2.84/device2025-06: 0 reports for this device; peer average 4.16/device2025-07: 0 reports for this device; peer average 2.88/device2025-08: 0 reports for this device; peer average 2.85/device2025-09: 0 reports for this device; peer average 2.66/device2025-10: 0 reports for this device; peer average 3.28/device2025-11: 0 reports for this device; peer average 3.18/device2025-12: 0 reports for this device; peer average 2.47/device2026-01: 0 reports for this device; peer average 2.95/device2026-02: 0 reports for this device; peer average 3.78/device2026-03: 0 reports for this device; peer average 2.97/device2026-04: 0 reports for this device; peer average 2.86/device2026-05: 0 reports for this device; peer average 2.87/device2026-06: 0 reports for this device; peer average 3.59/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.92
2019-0203.83
2019-0303.38
2019-0403.19
2019-0504
2019-0603.22
2019-0703.63
2019-0804.08
2019-0904.22
2019-1003.43
2019-1103.02
2019-1202.8
2020-0103.15
2020-0203.53
2020-0302.95
2020-0403.45
2020-0503.28
2020-0602.64
2020-0703.24
2020-0803.24
2020-0904.05
2020-1003.82
2020-1103.28
2020-1203.2
2021-0102.43
2021-0203.32
2021-0302.96
2021-0403.05
2021-0502.16
2021-0602.31
2021-0703.09
2021-0803.13
2021-0903.57
2021-1002.55
2021-1102.37
2021-1202.31
2022-0102.27
2022-0202.81
2022-0302.62
2022-0402.31
2022-0502.47
2022-0602.58
2022-0702.56
2022-0802.65
2022-0902.55
2022-1002.69
2022-1104.2
2022-1203.19
2023-0104.29
2023-0204.73
2023-0305.6
2023-0404.98
2023-0505
2023-0605.14
2023-0706.02
2023-0805.7
2023-0905.14
2023-1004.48
2023-1103.85
2023-1205.61
2024-0104.24
2024-0207.28
2024-0308.65
2024-04013.36
2024-05017.87
2024-06016.58
2024-07013.72
2024-0809.31
2024-0907.24
2024-1005.47
2024-1103.94
2024-1204.21
2025-0102.94
2025-0202.37
2025-0302.97
2025-0403.33
2025-0502.84
2025-0604.16
2025-0702.88
2025-0802.85
2025-0902.66
2025-1003.28
2025-1103.18
2025-1202.47
2026-0102.95
2026-0203.78
2026-0302.97
2026-0402.86
2026-0502.87
2026-0603.59
This device (reports/month)Average device in FMF (reports/device/month)

Regulatory clearances

  • K243580 SESE 2025-02-05 (k number procode)

Predicate lineage

K243580 — cites (transitively): K170675 (d1), K180937 (d1), K142611 (d2), K142661 (d2), K161568 (d2), K130943 (d3), K132699 (d3), K121476 (d3), K141245 (d3), K063091 (d4), K131007 (d4) — cited as predicate by K253604

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

Manufacturer compliance record — Surgentec, LLC

  • NAI 2022-12-14 SurGenTec, LLC · 0 citations
  • NAI 2022-12-14 SurGenTec, LLC · 0 citations
  • VAI 2019-04-18 SurGenTec, LLC · 3 citations
  • VAI 2019-04-18 SurGenTec, LLC · 3 citations