510(k) Report

FDA applicant

Koya Medical, Inc.

Oakland, CA3 decisions2021–20240 recalls

FDA records 3 decisions for Koya Medical, Inc. (Oakland, CA) from 2021 to 2024: 3 510(k) clearances. All are in product code JOW (Sleeve, Limb, Compressible). Since 2016 its 510(k)s took a median of 62 days from receipt to decision, against 132 for FDA’s reviews in the same codes and years. Its devices cite 6 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2024

2021: 22024: 1
2021high 2 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

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

Planning a device like Koya Medical, Inc.’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?

  • JOWSleeve, Limb, Compressible3decisions

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 62 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 132 days; 2 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 2 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 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.

  • K210885DayspringKoya Medical, Inc. · 20213cite it
  • K223228DayspringKoya Medical, Inc. · 20241cites it

What has FDA decided for it lately?

  • K223228DayspringKoya Medical, Inc. · 2024
  • K212287Dayspring LiteKoya Medical, Inc. · 2021
  • K210885DayspringKoya Medical, Inc. · 2021

All 3 as Koya Medical, Inc. →

Other applicant names beginning “Koya”

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

Koya, Inc. 1