510(k) Report

FDA applicant

Devoro Medical, Inc.

Fremont, CA5 decisions2020–20240 recalls

FDA records 5 decisions for Devoro Medical, Inc. (Fremont, CA) from 2020 to 2024: 5 510(k) clearances. All are in product code QEW (Peripheral Mechanical Thrombectomy With…). Since 2016 its 510(k)s took a median of 181 days from receipt to decision, against 65 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 4 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 Devoro Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2020: 12021: 22022: 12024: 1
2020high 2 (2021) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Devoro Medical, Inc. by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Devoro 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?

  • QEWPeripheral Mechanical Thrombectomy With Aspiration5decisions

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 181 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 65 days; 2 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 6 predicates; 4 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.

  • K200101WOLF Thrombectomy V SystemDevoro Medical, Inc. · 20202cite it
  • K210911WOLF Thrombectomy System, 14FDevoro Medical, Inc. · 20211cites it
  • K221391WOLF Thrombectomy™ SmartClaw CatheterDevoro Medical, Inc. · 20221cites it

What has FDA decided for it lately?

  • K241207SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02)Devoro Medical, Inc. · 2024
  • K221391WOLF Thrombectomy™ SmartClaw CatheterDevoro Medical, Inc. · 2022
  • K210911WOLF Thrombectomy System, 14FDevoro Medical, Inc. · 2021
  • K210530WOLF Thrombectomy System, 6FDevoro Medical, Inc. · 2021
  • K200101WOLF Thrombectomy V SystemDevoro Medical, Inc. · 2020

All 5 as Devoro Medical, Inc. →