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EnsoSleep

Model 01.1 · Ensodata, Inc. · DI 00864458000407

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

UDILibrary device dossier · generated 2026-09-14 · 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.

01122025-01: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 1.5/device0108
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2025-0101
2025-0801.5
This device (reports/month)Average device in OLZ (reports/device/month)

Regulatory clearances

  • K162627 SESE 2017-03-31 (k number procode)

Predicate lineage

K162627 — cites (transitively): K112102 (d1), K120450 (d1), K130007 (d1), K153412 (d1), K022506 (d2), K040595 (d2), K083620 (d2), K112514 (d2), K082968 (d3), K111194 (d3), K021176 (d4), K071230 (d4), K072201 (d4), K090484 (d4), K110705 (d4) — cited as predicate by K210034, K221179, K223922, K250058, K253390, K253668

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

Manufacturer compliance record — Ensodata, Inc.

Nothing in the loaded window.