Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

CystoFlex™F

Model 211-0146 · MAUNA KEA TECHNOLOGIES · DI 03760187910123

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

  • K132389 SESE 2014-02-25 (k number procode)

Predicate lineage

K132389 — cites (transitively): K011496 (d1), K043022 (d1), K091962 (d1), K111047 (d1), K123676 (d1), K051585 (d2), K061666 (d2), K092359 (d2), K120208 (d2), K122042 (d2), K050403 (d3), K052194 (d3) — cited as predicate by K150831

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