Cleared Traditional

MODEL #535 PACU STRETCHER/BED & #530 ED/TRAUMA STR (K894335) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K894335 · Midmark Corp. · General Hospital
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Sep 1989
Decision
60d
Days
Class 2
Risk

K894335 is an FDA 510(k) clearance for the MODEL #535 PACU STRETCHER/BED & #530 ED/TRAUMA STR. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Midmark Corp. (Versailles, US). The FDA issued a Cleared decision on September 12, 1989 after a review of 60 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5860 - 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 Midmark Corp. devices

Submission Details

510(k) Number K894335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1989
Decision Date September 12, 1989
Days to Decision 60 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
69d faster than avg
Panel avg: 129d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FMF Syringe, Piston
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5860
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.

Regulatory Peers - FMF Syringe, Piston

All 208
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K894335.
BECTON DICKINSON SAFETY-LOK SYRINGE
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K883955 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1988
BD MICROFINE IV PEN INJECTOR
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