Cleared Traditional

K852095 - ESP EMERGENCY CARE KIT (FDA 510(k) Clearance)

K852095 · Emergency Situation Products · General & Plastic Surgery device
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Jul 1985
Decision
58d
Days
-
Risk

K852095 is an FDA 510(k) clearance for the ESP EMERGENCY CARE KIT.

Submitted by Emergency Situation Products (Memphis, US). The FDA issued a Cleared decision on July 11, 1985 after a review of 58 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Emergency Situation Products devices

Submission Details

510(k) Number K852095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received May 14, 1985
Decision Date July 11, 1985
Days to Decision 58 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 114d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -