Cleared Traditional

SAFETYMATE TALKING FIRST AID (K110625) - FDA 510(k) Clearance

Class I General Hospital device.

K110625 · Safetymate, Inc. · General Hospital
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Jun 2011
Decision
105d
Days
Class 1
Risk

K110625 is an FDA 510(k) clearance for the SAFETYMATE TALKING FIRST AID. Classified as Kit, First Aid, Talking (product code OVR), Class I - General Controls.

Submitted by Safetymate, Inc. (Costa Mcsa, US). The FDA issued a Cleared decision on June 17, 2011 after a review of 105 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4014 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Safetymate, Inc. devices

Submission Details

510(k) Number K110625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2011
Decision Date June 17, 2011
Days to Decision 105 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 129d · This submission: 105d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OVR Kit, First Aid, Talking
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4014
Definition 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.