510(k) Report

FDA applicant

Prosomnus Sleep Technologies

Pleasanton, CA3 decisions2020–20260 recalls

FDA records 3 decisions for Prosomnus Sleep Technologies (Pleasanton, CA) from 2020 to 2026: 3 510(k) clearances. Most are in product codes LRK (Device, Anti-Snoring) and PLC (Sleep Appliances With Patient Monitoring). Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Prosomnus Sleep Technologies, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Prosomnus Sleep Technologies’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2020: 12022: 12026 (partial year): 1
2020high 1 (2020) · low 0 (2021)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Prosomnus Sleep Technologies by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Prosomnus Sleep Technologies’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LRKDevice, Anti-Snoring2decisions
  • PLCSleep Appliances With Patient Monitoring1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K252765ProSomnus RPMO2 OSA Device (RPMO2 OSA)Prosomnus Sleep Technologies · 20261cites it
  • K202529ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient MonitoringProsomnus Sleep Technologies, Inc. · 20201cites it

What has FDA decided for it lately?

  • K252765ProSomnus RPMO2 OSA Device (RPMO2 OSA)Prosomnus Sleep Technologies · 2026
  • K221889ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient MonitoringProsomnus Sleep Technologies · 2022
  • K202529ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient MonitoringProsomnus Sleep Technologies, Inc. · 2020

All 2 as Prosomnus Sleep Technologies →The one decision as Prosomnus Sleep Technologies, Inc. →