510(k) Report

FDA applicant

Truer Medical, Inc.

Orange, CA2 decisions2009–20100 recalls

FDA records 2 decisions for Truer Medical, Inc. (Orange, CA) from 2009 to 2010: 2 510(k) clearances. Most are in product codes FLL (Continuous Measurement Thermometer) and BZT (Stethoscope, Esophageal, With Electrical…). 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 Truer Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2009: 12010: 1
2009high 1 (2009) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2009.

FIG. 1 — Truer Medical, Inc. by year, 2009–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Truer Medical, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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