FDA applicant

True Indicating, LLC

Toledo, OH6 decisions2020–20260 recalls

FDA records 6 decisions for True Indicating, LLC (Toledo, OH) from 2020 to 2026: 6 510(k) clearances. Most are in product codes JOJ (Indicator, Physical/Chemical Sterilization…) and FRC (Indicator, Biological Sterilization Process). Since 2016 its 510(k)s took a median of 260 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 6 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, general hospital panel, where it files most

How often FDA has decided True Indicating, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2020high 1 (2020) · low 0 (2023)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

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

Planning a device like True Indicating, LLC’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 “True”

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

True Function Laboratory, Inc. 3 True Glove Factory 2 True Diagnostics, Inc. 2 True Wearables, Inc. 1

True Indicating, LLC

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “True”