Cleared Traditional

K790411 - AUTO TRAUMA KIT

K790411 is the FDA 510(k) clearance for AUTO TRAUMA KIT by Marshall Electronics, Inc.. It is a Class 1 General Hospital device (product code KME) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K790411 · Marshall Electronics, Inc. · General Hospital
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Jun 1979
Decision
95d
Days
Class 1
Risk

K790411 is an FDA 510(k) clearance for the AUTO TRAUMA KIT. Classified as Bedding, Disposable, Medical (product code KME), Class I - General Controls.

Submitted by Marshall Electronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 1, 1979 after a review of 95 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6060 - 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 Marshall Electronics, Inc. devices

Submission Details

510(k) Number K790411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 1979
Decision Date June 01, 1979
Days to Decision 95 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 129d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KME Bedding, Disposable, Medical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6060
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 - KME Bedding, Disposable, Medical

All 18
Devices cleared under the same product code (KME) and FDA review panel - the closest regulatory comparables to K790411.
3M THINSULATE DISPOSABLE HOSPITAL BED
K820582 · 3M Company · Mar 1982
DISPOSABLE PILLOW
K810264 · Anago, Inc. · Feb 1981
STERILIZATION PROCESS/BABY BLANKET
K792626 · Procter & Gamble Mfg. Co. · Jan 1980
PILLOW, CARTER ARM ELEVATION
K790283 · Depuy, Inc. · Apr 1979
BEDDING, DISPOSABLE HOSPITAL
K781796 · Kimberly-Clark Corp. · Dec 1978
TOWELS, SHEETS, PILLOWCASES
K781227 · Abco Dealers, Inc. · Oct 1978