# K110625: Safetymate Talking First Aid

- Pathway: 510(k) (Traditional)
- Applicant: Safetymate, Inc.
- Decided: Jun 17, 2011 after 105 days
- Product code: OVR (Kit, First Aid, Talking)
- Device class: 1
- Regulation: 21 CFR 878.4014
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) 510(k) Exempt First Aid Kits Without Drugs: named in the summary without a submission number

## Indications for use
SafetyMate® Talking First Aid, SM200 Series is an electronic device intended for use to provide verbal information from established sources to refresh how to handle common medical emergencies through utilization of button options, voice queries and prompts which remind the user of important points in the management of identified emergency situations for infant, chid, and adult emergencies.

Source page: https://510kreport.com/device/K110625
Methodology: https://510kreport.com/methodology