Cleared Traditional

ALKA FIRST AID KIT (K831657) - FDA 510(k) Clearance

K831657 · Alka, Inc. · General & Plastic Surgery device
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Aug 1983
Decision
93d
Days
-
Risk

K831657 is an FDA 510(k) clearance for the ALKA FIRST AID KIT. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Alka, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 24, 1983 after a review of 93 days - within the typical 510(k) review window.

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

View all Alka, Inc. devices

Submission Details

510(k) Number K831657 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1983
Decision Date August 24, 1983
Days to Decision 93 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
22d faster than avg
Panel avg: 115d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 169
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K831657.
BARD OCCLUSIVE WOUND DRESSING
K850889 · C.R. Bard, Inc. · Jul 1985
J & J ULCER DRESSING
K850451 · Johnson & Johnson Professionals, Inc. · Jun 1985
BARD ABSORPTION DRESSING
K831710 · C.R. Bard, Inc. · Jan 1984
PVP GEL DRESSING
K820635 · Johnson & Johnson Professionals, Inc. · Aug 1982
TEGADERM TRANSPARENT DRESSING
K812678 · 3M Company · Jan 1982