510(k) Report

FDA applicant

Huxley Medical

Atlanta, GA4 decisions2024–20250 recalls

FDA records 4 decisions for Huxley Medical (Atlanta, GA) from 2024 to 2025: 4 510(k) clearances. All are in product code MNR (Ventilatory Effort Recorder). Since 2016 its 510(k)s took a median of 145 days from receipt to decision, against 165 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 2 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 Huxley Medical’s devices, and how often a recall has named them.

FDA decisions per year

3in 2025

2024: 12025: 3
2024high 3 (2025) · low 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — Huxley Medical by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Huxley Medical’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?

  • MNRVentilatory Effort Recorder4decisions

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 145 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 165 days; 3 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 2 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.

  • K244027Sansa HsatHuxley Medical · 20252cite it
  • K240285Huxley SANSA Home Sleep Apnea Test (1000-00)Huxley Medical · 20241cites it

What has FDA decided for it lately?

  • K252497Sansa HsatHuxley Medical · 2025
  • K250882Sansa HsatHuxley Medical · 2025
  • K244027Sansa HsatHuxley Medical · 2025
  • K240285Huxley SANSA Home Sleep Apnea Test (1000-00)Huxley Medical · 2024

All 4 as Huxley Medical →

Other applicant names beginning “Huxley”

FDA records each applicant name separately; these may or may not be the same firm.

The Huxley Instrument Corp. 53