Cleared Traditional

K790411 - AUTO TRAUMA KIT

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

K790411 · Marshall Electronics, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K790411

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.

KME Device Classification - Class 1, General Controls

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 26
Devices cleared under the same product code (KME) and FDA review panel - the closest regulatory comparables to K790411.
DISPOSABLE PILLOW
K810264 · Anago, Inc. · Feb 1981
PATIENT CARE DISPOSABLE INFANT SHIRTS
K802998 · American Convertors Div., American Pharmaseal · Dec 1980
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