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Cerebra Sleep System

Model 700014 · Cerebra Medical Ltd · DI B600700014

OLV — Standard Polysomnograph With Electroencephalograph · Class II · 21 CFR 882.1400

OLZ — Automatic Event Detection Software For Polysomnograph With Electroencephalograph · Class II · 21 CFR 882.1400

OMC — Reduced- Montage Standard Electroencephalograph · Class II · 21 CFR 882.1400

UDILibrary device dossier · generated 2026-09-12 · 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.

12352019-01: 0 reports for this device; peer average 2/device2019-06: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 2/device2022-05: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 4.33/device2024-04: 0 reports for this device; peer average 1.5/device2024-06: 0 reports for this device; peer average 2/device2024-09: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1/device2025-02: 0 reports for this device; peer average 2/device2025-03: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 1.25/device2025-07: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 1.67/device2025-09: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 1.5/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 1/device2026-01: 0 reports for this device; peer average 3/device2026-02: 0 reports for this device; peer average 4/device2026-03: 0 reports for this device; peer average 3/device2026-04: 0 reports for this device; peer average 4.5/device2026-05: 0 reports for this device; peer average 1.5/device2026-06: 0 reports for this device; peer average 2/device010609100205101112050406090102030406070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-0601
2021-0902
2021-1001
2022-0202
2022-0501
2022-1001
2022-1101
2022-1201
2023-0504.33
2024-0401.5
2024-0602
2024-0901
2025-0101
2025-0202
2025-0302
2025-0402
2025-0601.25
2025-0701
2025-0801.67
2025-0901
2025-1001.5
2025-1101
2025-1201
2026-0103
2026-0204
2026-0303
2026-0404.5
2026-0501.5
2026-0602
This device (reports/month)Average device in OLV, OLZ, OMC (reports/device/month)

Regulatory clearances

  • K213007 SESE 2022-07-06 (k number procode)

Predicate lineage

K213007 — cites (transitively): K010638 (d1), K040595 (d1), K042253 (d1), K072201 (d1), K102350 (d1), K112102 (d1), K120888 (d1), K152040 (d1), K781430 (d1), K842514 (d1), K850108 (d1), K903300 (d1), K913395 (d1), K970639 (d1), K033307 (d2), K022506 (d2), K083620 (d2), K022121 (d2), K050833 (d2), K011397 (d2), K112514 (d2), K120047 (d2), K130013 (d2), K131383 (d2), K864722 (d2), K945479 (d2), K960968 (d2), K082968 (d3), K111194 (d3), K061342 (d3), K070962 (d3), K091266 (d3), K120447 (d3), K021176 (d4), K071230 (d4), K090484 (d4), K110705 (d4)

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

Manufacturer compliance record — Cerebra Medical Ltd

Nothing in the loaded window.