FDA applicant

Inova Labs, Inc.

Austin, TX3 decisions2011–20200 recalls

FDA records 3 decisions for Inova Labs, Inc. (Austin, TX) from 2011 to 2020: 3 510(k) clearances. Most are in product codes CAW (Generator, Oxygen, Portable) and JOW (Sleeve, Limb, Compressible). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Inova Labs”.

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 Inova Labs, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2020

2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2011.

FIG. 1 — Inova Labs, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Inova Labs, Inc.’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 “Inova”

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

Inova Diagnostics, Inc. 138

Inova Labs, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Inova”