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

"Serenity RIP01 RIP Belt, Small - 15""-27"""

Model RIP01 · Neurotronics, LLC · DI 00817111020939

OLV — Standard Polysomnograph With 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.

11222019-01: 0 reports for this device; peer average 2/device2019-06: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 2/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/device2024-04: 0 reports for this device; peer average 2/device2024-06: 0 reports for this device; peer average 2/device2025-01: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 2/device0106021011120406010910
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
2022-0202
2022-1001
2022-1101
2022-1201
2024-0402
2024-0602
2025-0101
2025-0901
2025-1002
This device (reports/month)Average device in OLV (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K173868 — cites (transitively): K092699 (d1), K142774 (d1), K903300 (d1), K981969 (d1), K010460 (d2), K011204 (d2), K012686 (d2), K022121 (d2), K033475 (d2), K050833 (d2), K062943 (d2), K080546 (d2), K113117 (d2), K120888 (d2), K992742 (d2) — cited as predicate by K251480

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

Manufacturer compliance record — Neurotronics, LLC

  • NAI 2023-10-26 Neurotronics LLC. · 0 citations
  • NAI 2023-10-26 Neurotronics LLC. · 0 citations
  • VAI 2022-05-05 Neurotronics LLC. · 1 citations
  • VAI 2022-05-05 Neurotronics LLC. · 1 citations
  • VAI 2017-11-15 Neurotronics LLC. · 3 citations
  • VAI 2017-11-15 Neurotronics LLC. · 3 citations
  • VAI 2013-12-04 Neurotronics LLC. · 1 citations
  • VAI 2013-12-04 Neurotronics LLC. · 1 citations
  • VAI 2010-08-31 Neurotronics LLC. · 2 citations
  • VAI 2010-08-31 Neurotronics LLC. · 2 citations