Cleared Traditional

K843439 - CENTURIAN HYDRAULIC STRETCHER

K843439 is an FDA 510(k) clearance for CENTURIAN HYDRAULIC STRETCHER, manufactured by American Sterilizer Co.. The device is a Class 2 General Hospital device with product code FPO cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K843439 · American Sterilizer Co. · General Hospital
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Sep 1984
Decision
9d
Days
Class 2
Risk

K843439 is an FDA 510(k) clearance for the CENTURIAN HYDRAULIC STRETCHER. Classified as Stretcher, Wheeled (product code FPO), Class II - Special Controls.

Submitted by American Sterilizer Co. (Mchenry, US). The FDA issued a Cleared decision on September 13, 1984 after a review of 9 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6910 - 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.

View all American Sterilizer Co. devices

FDA 510(k) Submission Details - K843439

510(k) Number K843439 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1984
Decision Date September 13, 1984
Days to Decision 9 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
120d faster than avg
Panel avg: 129d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPO Device Classification - Class 2, Special Controls

Product Code FPO Stretcher, Wheeled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6910
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.