Cleared Traditional

K831795 - FIRST AID KITS

K831795 is the FDA 510(k) clearance for FIRST AID KITS by I M, Inc.. It is a Class 1 General & Plastic Surgery device (product code KDD) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K831795 · I M, Inc. · General & Plastic Surgery device
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Sep 1983
Decision
90d
Days
Class 1
Risk

K831795 is an FDA 510(k) clearance for the FIRST AID KITS. Classified as Kit, Surgical Instrument, Disposable (product code KDD), Class I - General Controls.

Submitted by I M, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 1, 1983 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all I M, Inc. devices

Submission Details

510(k) Number K831795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1983
Decision Date September 01, 1983
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KDD Kit, Surgical Instrument, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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.

Regulatory Peers - KDD Kit, Surgical Instrument, Disposable

All 16
Devices cleared under the same product code (KDD) and FDA review panel - the closest regulatory comparables to K831795.
ENTERON ABDOMINAL PARACENTESIS TRAY
K874063 · Endovations · Dec 1987
C-SECTION TRAY
K842627 · Deroyal Industries, Inc. · Sep 1984
STERILE SUTURE BOOTS
K834135 · Devon Industries, Inc. · Apr 1984
ACKRAD INCISION & DRAIN SET
K813103 · Ackrad Laboratories · Dec 1981
LARGE WOUND DRESSING KIT
K803119 · American Medical Disposable, Inc. · Dec 1980
CUSTOM DRESSING TRAY WET TO DRY
K803117 · American Medical Disposable, Inc. · Dec 1980