510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K963276Substantially Equivalent

The Safety 1St Digital Pacifier

Safety 1st, Inc., Chestnut Hill MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963276 is the FDA 510(k) clearance record for THE SAFETY 1ST DIGITAL PACIFIER, a class II device, cleared for Safety 1st, Inc. on under FDA product code FLL (Continuous Measurement Thermometer). FDA's definition for product code FLL reads: "A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. Under this regulation, this product code represents non-exempt...". FDA records list one 510(k) clearance for Safety 1st, Inc. As of , FDA records show no recalls naming K963276.

Clearance record

Decision date
Received
(108 days to decision)
Product code
FLL Continuous Measurement Thermometer
Regulation
21 CFR 880.2910
Device class
Class II
Review panel
General Hospital
Applicant
Safety 1st, Inc. 210 Boylston St., Chestnut Hill MA
510(k) summary
Statement
Third party review
No

Clearances, product code FLL

Trailing 12 months
2 clearances under product code FLL in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FLL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260