Cleared Traditional

K840034 - VACUUM STRETCHER IMMOBILIZER

K840034 is an FDA 510(k) clearance for VACUUM STRETCHER IMMOBILIZER, manufactured by Medicon, Inc.. The device is a Class 1 General Hospital device with product code FPP cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K840034 · Medicon, Inc. · General Hospital
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Feb 1984
Decision
53d
Days
Class 1
Risk

K840034 is an FDA 510(k) clearance for the VACUUM STRETCHER IMMOBILIZER. Classified as Stretcher, Hand-carried (product code FPP), Class I - General Controls.

Submitted by Medicon, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 27, 1984 after a review of 53 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6900 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K840034

510(k) Number K840034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1984
Decision Date February 27, 1984
Days to Decision 53 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 129d · This submission: 53d
Pathway characteristics
Predicate-based equivalence.

FPP Device Classification - Class 1, General Controls

Product Code FPP Stretcher, Hand-carried
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6900
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 - FPP Stretcher, Hand-carried

All 37
Devices cleared under the same product code (FPP) and FDA review panel - the closest regulatory comparables to K840034.
BACK REST, LITTER, NON-ADJUSTABLE
K863686 · Brenner Metal Prod Corp. · Jan 1987
IMMOBILIZING VACUUM MATRESS (IVM)
K863511 · Omnium Services Partners, Inc. · Sep 1986
DONWAY LIFTING FRAME
K851660 · Australian Biomedical Corporation , Ltd. · Aug 1985
INFANT EVALUATION CARRIER
K831731 · E.M. Adams · Jul 1983
MATELAS COQUILLE LATTREDE TASSIGNY
K811547 · Firn-France · Jun 1981
ARALUEN HEAD SHIELD
K810868 · Araluen, Inc. · May 1981
K840034 · VACUUM STRETCHER IMMOBILIZER
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