FDA applicant

True Function Laboratory, Inc.

La Mesa, CA3 decisions2017–20260 recalls

FDA records 3 decisions for True Function Laboratory, Inc. (La Mesa, CA) from 2017 to 2026: 3 510(k) clearances. All are in product code LRK (Device, Anti-Snoring). Since 2016 its 510(k)s took a median of 270 days from receipt to decision, against 150 for FDA’s reviews in the same codes and years. Its devices cite 3 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, dental panel, where it files most

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

FDA decisions per year

1in 2019

2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — True Function Laboratory, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like True Function Laboratory, 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 “True”

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

True Indicating, LLC 6 True Glove Factory 2 True Diagnostics, Inc. 2 True Wearables, Inc. 1

True Function Laboratory, Inc.

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”