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4Klear

Model 4KL100.6M · Nds Surgical Imaging LLC · DI 00817613020536

KQM — Camera, Surgical And Accessories · Class I · 21 CFR 878.4160

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.

163147622019-12: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 1.67/device2020-03: 0 reports for this device; peer average 2/device2020-05: 0 reports for this device; peer average 4/device2020-06: 0 reports for this device; peer average 7/device2020-07: 0 reports for this device; peer average 11/device2020-08: 0 reports for this device; peer average 3.67/device2020-09: 0 reports for this device; peer average 5/device2020-10: 0 reports for this device; peer average 3.5/device2020-11: 0 reports for this device; peer average 7/device2020-12: 0 reports for this device; peer average 5/device2021-01: 0 reports for this device; peer average 6/device2021-03: 0 reports for this device; peer average 4/device2021-04: 0 reports for this device; peer average 9/device2021-05: 0 reports for this device; peer average 4/device2021-06: 0 reports for this device; peer average 5.5/device2021-07: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 1.5/device2021-09: 0 reports for this device; peer average 3/device2021-10: 0 reports for this device; peer average 6/device2021-11: 0 reports for this device; peer average 6/device2021-12: 0 reports for this device; peer average 2/device2022-01: 0 reports for this device; peer average 4/device2022-02: 0 reports for this device; peer average 6/device2022-03: 0 reports for this device; peer average 4.33/device2022-04: 0 reports for this device; peer average 8/device2022-05: 0 reports for this device; peer average 12/device2022-06: 0 reports for this device; peer average 4.5/device2022-07: 0 reports for this device; peer average 6/device2022-09: 0 reports for this device; peer average 3.5/device2022-10: 0 reports for this device; peer average 5/device2022-11: 0 reports for this device; peer average 3.67/device2022-12: 0 reports for this device; peer average 4/device2023-01: 0 reports for this device; peer average 2/device2023-02: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 5.5/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 1/device2023-06: 0 reports for this device; peer average 2/device2023-07: 0 reports for this device; peer average 2.75/device2023-08: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 5/device2023-10: 0 reports for this device; peer average 1.67/device2023-12: 0 reports for this device; peer average 6/device2024-01: 0 reports for this device; peer average 2/device2024-02: 0 reports for this device; peer average 1.5/device2024-03: 0 reports for this device; peer average 1.8/device2024-05: 0 reports for this device; peer average 4/device2024-06: 0 reports for this device; peer average 5.5/device2024-07: 0 reports for this device; peer average 2.67/device2024-08: 0 reports for this device; peer average 1/device2024-09: 0 reports for this device; peer average 4/device2024-10: 0 reports for this device; peer average 2/device2024-11: 0 reports for this device; peer average 2/device2024-12: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 1.5/device2025-07: 0 reports for this device; peer average 2.33/device2025-08: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 5/device2025-11: 0 reports for this device; peer average 2/device2025-12: 0 reports for this device; peer average 3/device2026-01: 0 reports for this device; peer average 8.83/device2026-02: 0 reports for this device; peer average 13.75/device2026-03: 0 reports for this device; peer average 15.14/device2026-04: 0 reports for this device; peer average 18.83/device2026-05: 0 reports for this device; peer average 7.67/device2026-06: 0 reports for this device; peer average 62.19/device12010305060708091011120103040506070809101112010203040506070910111201020304050607080910120102030506070809101112060708101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-1201
2020-0101.67
2020-0302
2020-0504
2020-0607
2020-07011
2020-0803.67
2020-0905
2020-1003.5
2020-1107
2020-1205
2021-0106
2021-0304
2021-0409
2021-0504
2021-0605.5
2021-0702
2021-0801.5
2021-0903
2021-1006
2021-1106
2021-1202
2022-0104
2022-0206
2022-0304.33
2022-0408
2022-05012
2022-0604.5
2022-0706
2022-0903.5
2022-1005
2022-1103.67
2022-1204
2023-0102
2023-0202
2023-0305.5
2023-0401
2023-0501
2023-0602
2023-0702.75
2023-0801
2023-0905
2023-1001.67
2023-1206
2024-0102
2024-0201.5
2024-0301.8
2024-0504
2024-0605.5
2024-0702.67
2024-0801
2024-0904
2024-1002
2024-1102
2024-1202
2025-0601.5
2025-0702.33
2025-0801
2025-1005
2025-1102
2025-1203
2026-0108.83
2026-02013.75
2026-03015.14
2026-04018.83
2026-0507.67
2026-06062.19
This device (reports/month)Average device in KQM (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Nds Surgical Imaging LLC

  • VAI 2026-02-13 NDS Surgical Imaging LLC · 1 citations
  • VAI 2026-02-13 NDS Surgical Imaging LLC · 1 citations
  • NAI 2015-03-25 NDS Surgical Imaging LLC · 1 citations
  • NAI 2015-03-25 NDS Surgical Imaging LLC · 1 citations
  • VAI 2012-08-17 NDS Surgical Imaging LLC · 4 citations
  • VAI 2012-08-17 NDS Surgical Imaging LLC · 4 citations
  • VAI 2012-04-20 NDS Surgical Imaging LLC · 1 citations
  • VAI 2012-04-20 NDS Surgical Imaging LLC · 1 citations
  • VAI 2010-07-21 NDS Surgical Imaging LLC · 1 citations
  • VAI 2010-07-21 NDS Surgical Imaging LLC · 1 citations