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EnsoSleep

Model 7.0 · Ensodata, Inc. · DI 00864458000414

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

UDILibrary device dossier · generated 2026-09-07 · 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

  • K210034 SESE 2021-06-16 (k number procode)

Predicate lineage

K210034 — cites (transitively): K112102 (d1), K162627 (d1), K022506 (d2), K040595 (d2), K083620 (d2), K120450 (d2), K130007 (d2), K153412 (d2), K112514 (d3), K082968 (d4), K111194 (d4), K021176 (d5), K071230 (d5), K072201 (d5), K090484 (d5), K110705 (d5) — cited as predicate by K250851, K253390

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

Manufacturer compliance record — Ensodata, Inc.

Nothing in the loaded window.