510(k) Report

FDA applicant

Intervene

Redwood City, CA2 decisions2023–20250 recalls

FDA records 2 decisions for Intervene (Redwood City, CA) from 2023 to 2025: 2 510(k) clearances. Most are in product codes QEW (Peripheral Mechanical Thrombectomy With…) and NPG (Catheter, Infusion, Syringe). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Intervene, Inc.”.

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

FDA decisions per year

1in 2025

2023: 12025: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2023.

FIG. 1 — Intervene by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Intervene’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

Other applicant names beginning “Intervene”

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