510(k) Report

FDA applicant

Ortho8, Inc.

Rocklin, CA3 decisions2021–20220 recalls

FDA records 3 decisions for Ortho8, Inc. (Rocklin, CA) from 2021 to 2022: 3 510(k) clearances. All are in product code JOW (Sleeve, Limb, Compressible). Since 2016 its 510(k)s took a median of 80 days from receipt to decision, against 132 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 0 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 Ortho8, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2021: 22022: 1
2021high 2 (2021) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Ortho8, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ortho8, 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 80 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; 1 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K220761CIRCUL8 Connect DVT Prevention DeviceOrtho8, Inc. · 2022
  • K212731Circul8 ProOrtho8, Inc. · 2021
  • K211235CIRCUL8 Luxe DVT Prevention DeviceOrtho8, Inc. · 2021

All 3 as Ortho8, Inc. →