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CranioFlex™-C

Model 211-0175 · MAUNA KEA TECHNOLOGIES · DI 03760187910765

GWG — Endoscope, Neurological · Class II · 21 CFR 882.1480

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

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.

51014192019-01: 0 reports for this device; peer average 1.25/device2019-03: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1.75/device2019-05: 0 reports for this device; peer average 1.5/device2019-06: 0 reports for this device; peer average 1.4/device2019-07: 0 reports for this device; peer average 1.5/device2019-08: 0 reports for this device; peer average 1.4/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 2.75/device2020-03: 0 reports for this device; peer average 2.25/device2020-04: 0 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 1.75/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/device2020-09: 0 reports for this device; peer average 2.6/device2020-10: 0 reports for this device; peer average 2.6/device2020-11: 0 reports for this device; peer average 2.22/device2020-12: 0 reports for this device; peer average 2.25/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 2.8/device2021-04: 0 reports for this device; peer average 4.43/device2021-05: 0 reports for this device; peer average 3.4/device2021-06: 0 reports for this device; peer average 2.88/device2021-07: 0 reports for this device; peer average 3.13/device2021-08: 0 reports for this device; peer average 3.22/device2021-09: 0 reports for this device; peer average 3.83/device2021-10: 0 reports for this device; peer average 2.83/device2021-11: 0 reports for this device; peer average 3.13/device2021-12: 0 reports for this device; peer average 5.5/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 4.88/device2022-05: 0 reports for this device; peer average 12.63/device2022-06: 0 reports for this device; peer average 9.43/device2022-07: 0 reports for this device; peer average 5.57/device2022-08: 0 reports for this device; peer average 4.23/device2022-09: 0 reports for this device; peer average 3.67/device2022-10: 0 reports for this device; peer average 4/device2022-11: 0 reports for this device; peer average 5.55/device2022-12: 0 reports for this device; peer average 4.75/device2023-01: 0 reports for this device; peer average 4.56/device2023-02: 0 reports for this device; peer average 3.64/device2023-03: 0 reports for this device; peer average 6/device2023-04: 0 reports for this device; peer average 6.78/device2023-05: 0 reports for this device; peer average 6.7/device2023-06: 0 reports for this device; peer average 4.42/device2023-07: 0 reports for this device; peer average 5.6/device2023-08: 0 reports for this device; peer average 7.13/device2023-09: 0 reports for this device; peer average 8.33/device2023-10: 0 reports for this device; peer average 6.55/device2023-11: 0 reports for this device; peer average 7/device2023-12: 0 reports for this device; peer average 8.88/device2024-01: 0 reports for this device; peer average 6.43/device2024-02: 0 reports for this device; peer average 14.38/device2024-03: 0 reports for this device; peer average 11.33/device2024-04: 0 reports for this device; peer average 10.2/device2024-05: 0 reports for this device; peer average 10.5/device2024-06: 0 reports for this device; peer average 14.5/device2024-07: 0 reports for this device; peer average 19/device2024-08: 0 reports for this device; peer average 13/device2024-09: 0 reports for this device; peer average 10.22/device2024-10: 0 reports for this device; peer average 12.25/device2024-11: 0 reports for this device; peer average 5.67/device2024-12: 0 reports for this device; peer average 9.67/device2025-01: 0 reports for this device; peer average 6.56/device2025-02: 0 reports for this device; peer average 3.29/device2025-03: 0 reports for this device; peer average 4.89/device2025-04: 0 reports for this device; peer average 3.92/device2025-05: 0 reports for this device; peer average 3.63/device2025-06: 0 reports for this device; peer average 3.77/device2025-07: 0 reports for this device; peer average 5.92/device2025-08: 0 reports for this device; peer average 4.75/device2025-09: 0 reports for this device; peer average 2.8/device2025-10: 0 reports for this device; peer average 3.32/device2025-11: 0 reports for this device; peer average 3.29/device2025-12: 0 reports for this device; peer average 3.91/device2026-01: 0 reports for this device; peer average 4.44/device2026-02: 0 reports for this device; peer average 3.3/device2026-03: 0 reports for this device; peer average 3.26/device2026-04: 0 reports for this device; peer average 5.79/device2026-05: 0 reports for this device; peer average 3.84/device2026-06: 0 reports for this device; peer average 3.25/device0103040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.25
2019-0301
2019-0401.75
2019-0501.5
2019-0601.4
2019-0701.5
2019-0801.4
2019-0901
2019-1002.75
2019-1102.5
2019-1205
2020-0101.67
2020-0202.75
2020-0302.25
2020-0401
2020-0501.75
2020-0604
2020-0702.17
2020-0802
2020-0902.6
2020-1002.6
2020-1102.22
2020-1202.25
2021-0103.4
2021-0202
2021-0302.8
2021-0404.43
2021-0503.4
2021-0602.88
2021-0703.13
2021-0803.22
2021-0903.83
2021-1002.83
2021-1103.13
2021-1205.5
2022-0103.71
2022-0208.4
2022-0306.33
2022-0404.88
2022-05012.63
2022-0609.43
2022-0705.57
2022-0804.23
2022-0903.67
2022-1004
2022-1105.55
2022-1204.75
2023-0104.56
2023-0203.64
2023-0306
2023-0406.78
2023-0506.7
2023-0604.42
2023-0705.6
2023-0807.13
2023-0908.33
2023-1006.55
2023-1107
2023-1208.88
2024-0106.43
2024-02014.38
2024-03011.33
2024-04010.2
2024-05010.5
2024-06014.5
2024-07019
2024-08013
2024-09010.22
2024-10012.25
2024-1105.67
2024-1209.67
2025-0106.56
2025-0203.29
2025-0304.89
2025-0403.92
2025-0503.63
2025-0603.77
2025-0705.92
2025-0804.75
2025-0902.8
2025-1003.32
2025-1103.29
2025-1203.91
2026-0104.44
2026-0203.3
2026-0303.26
2026-0405.79
2026-0503.84
2026-0603.25
This device (reports/month)Average device in GWG, OWN (reports/device/month)

Regulatory clearances

  • K180270 SESE 2018-05-22 (k number procode)

Predicate lineage

K180270 — cites (transitively): K111047 (d1), K133466 (d1), K150831 (d1), K161112 (d1), K172844 (d1), K051585 (d2), K061666 (d2), K122042 (d2), K123673 (d2), K123676 (d2), K132389 (d2), K141358 (d2), K002788 (d2), K160044 (d2), K151593 (d2), K160416 (d2), K171345 (d2), K050403 (d3), K052194 (d3), K120208 (d3), K092359 (d3), K011496 (d3), K043022 (d3), K091962 (d3), K013165 (d3), K131953 (d3), K070716 (d4) — cited as predicate by K181116, K191144

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