510(k) Report

FDA applicant

Safety 1st, Inc.

Chestnut Hill, MA1 decision1996–19960 recalls

FDA records 1 decision for Safety 1st, Inc. (Chestnut Hill, MA) in 1996: 1 510(k) clearance. All are in product code FLL (Continuous Measurement Thermometer). 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 Safety 1st, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Safety 1st, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Safety”

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