510(k) Report

FDA applicant

Fresca Medical, Inc.

San Clemente, CA2 decisions2018–20200 recalls

FDA records 2 decisions for Fresca Medical, Inc. (San Clemente, CA) from 2018 to 2020: 1 510(k) clearance and 1 De Novo grant. All are in product code QBY (Positive Airway Pressure System). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Fresca Medical”.

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

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

How often FDA has decided Fresca Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2018: 12020: 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Fresca Medical, Inc. by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

See the 510(k) Report

Which product codes does it file in?

  • QBYPositive Airway Pressure System2decisions

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • DEN170089Curve Positive Airway Pressure SystemFresca Medical · 20181cites it

What has FDA decided for it lately?

  • K200698Somnera SystemFresca Medical, Inc. · 2020
  • DEN170089Curve Positive Airway Pressure SystemFresca Medical · 2018

The one decision as Fresca Medical, Inc. →The one decision as Fresca Medical →