FDA applicant

Indilab, Inc.

Chicago, IL2 decisions1988–20110 recalls

FDA records 2 decisions for Indilab, Inc. (Chicago, IL) from 1988 to 2011: 2 510(k) clearances. All are in product code JOJ (Indicator, Physical/Chemical Sterilization…). Its devices cite 1 predicate, 1 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, general hospital panel, where it files most

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

FDA decisions per year

1in 2011

2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Indilab, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Indilab, 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

Indilab, Inc.

Which product codes does it file in?

Which of its devices are cited most?

What has FDA decided for it lately?