510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K110625Substantially Equivalent

Safetymate Talking First Aid

Safetymate, Inc., Costa Mcsa CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K110625 is the FDA 510(k) clearance record for SAFETYMATE TALKING FIRST AID, a class I device, cleared for Safetymate, Inc. on under FDA product code OVR (Kit, First Aid, Talking). FDA's definition for product code OVR reads: "The device provides verbal instructions pertaining to various first aid and common medical emergencies. The device does not contain any drug or supporting device that could be applied to the patient". FDA records list one 510(k) clearance for Safetymate, Inc. As of , FDA records show no recalls naming K110625.

Clearance record

Decision date
Received
(105 days to decision)
Product code
OVR Kit, First Aid, Talking
Regulation
21 CFR 878.4014
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
Safetymate, Inc. 1633 Monrovia Ave., Costa Mcsa CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OVR

Trailing 12 months

FDA records hold no clearances under product code OVR in the trailing twelve months.

FDA records show no clearances under product code OVR in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OVR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260