510(k) Report

FDA applicant

Wesper, Inc.

New York, NY4 decisions2021–20260 recalls

FDA records 4 decisions for Wesper, Inc. (New York, NY) from 2021 to 2026: 4 510(k) clearances. Most are in product codes MNR (Ventilatory Effort Recorder) and DQA (Oximeter). Since 2016 its 510(k)s took a median of 255 days from receipt to decision, against 205 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

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 Wesper, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2021: 12022: 12023: 12026 (partial year): 1
2021high 1 (2021) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Wesper, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Wesper, 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?

  • MNRVentilatory Effort Recorder3decisions
  • DQAOximeter1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 255 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 205 days; 1 of its 4 were faster than that.

Whose devices does it build on?

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

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K203343Wesper LabWesper, Inc. · 20211cites it

What has FDA decided for it lately?

  • K252628CassieWesper, Inc. · 2026
  • K221816Wesper LabWesper, Inc. · 2023
  • K213515WesperO2Wesper, Inc. · 2022
  • K203343Wesper LabWesper, Inc. · 2021

All 4 as Wesper, Inc. →