Cleared Traditional

K935092 - CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM

K935092 is an FDA 510(k) clearance for CONVENIENCE CONTOUR KITS REDI NURSE SYSTEM, manufactured by Contour Fabricators of Florida, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 228-day FDA review.

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

FDA 510(k) Submission Details - K935092

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
99d slower than avg
Panel avg: 129d · This submission: 228d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMF Device Classification - Class 2, Special Controls

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 316
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K935092.
IRRIGATION TRAY WITH PISTON SYRINGE
K942221 · Trinity Laboratories, Inc. · Aug 1994
SYRINGE
K942615 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1994
MEDSAVER SYRINGE
K941095 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1994
UNKNOWN
K941032 · Gelman Sciences, Inc. · May 1994
1ML LUER-LOK SYRINGE
K941562 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1994
BD MICRO FINE, ULTRA FINE, AND ALLERGY SYRINGE
K941657 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1994