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Sleep Profiler

Model Sleep Profiler Portal Software · ADVANCED BRAIN MONITORING, INC. · DI 00851113007024

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

  • K153412 SESE 2016-03-14 (k number procode)
  • K130007 SESE 2013-04-17 (k number procode)
  • K120450 SESE 2012-09-19 (k number procode)

Predicate lineage

K120450 — cites (transitively): K112102 (d1), K112514 (d1), K022506 (d2), K040595 (d2), K083620 (d2), K082968 (d2), K111194 (d2), K021176 (d3), K071230 (d3), K072201 (d3), K090484 (d3), K110705 (d3) — cited as predicate by K130007, K142825, K162627

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

K153412 — cites (transitively): K112514 (d1), K130007 (d1), K082968 (d2), K111194 (d2), K120450 (d2), K021176 (d3), K071230 (d3), K072201 (d3), K090484 (d3), K110705 (d3), K112102 (d3), K022506 (d4), K040595 (d4), K083620 (d4) — cited as predicate by K162627, K182227, K233438

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

Manufacturer compliance record — ADVANCED BRAIN MONITORING, INC.

  • VAI 2013-07-24 Advanced Brain Monitoring Inc · 3 citations
  • VAI 2013-07-24 Advanced Brain Monitoring Inc · 3 citations