Cleared Traditional

K935092 - CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM (FDA 510(k) Clearance)

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

K935092 · Contour Fabricators of Florida, Inc. · General Hospital
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Jun 1994
Decision
228d
Days
Class 2
Risk

K935092 is an FDA 510(k) clearance for the CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Contour Fabricators of Florida, Inc. (St. Petersburg, US). The FDA issued a Cleared decision on June 10, 1994 after a review of 228 days - an extended review 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: 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 Contour Fabricators of Florida, Inc. devices

Submission Details

510(k) Number K935092 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received October 25, 1993
Decision Date June 10, 1994
Days to Decision 228 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 128d · This submission: 228d
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 748
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