Cleared Traditional

K933335 - RIVER VIAL ADAPTER

K933335 is an FDA 510(k) clearance for RIVER VIAL ADAPTER, manufactured by River Medical, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 236-day FDA review.

K933335 · River Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
236d
Days
Class 2
Risk

K933335 is an FDA 510(k) clearance for the RIVER VIAL ADAPTER. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by River Medical, Inc. (San Diego, US). The FDA issued a Cleared decision on March 1, 1994 after a review of 236 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 River Medical, Inc. devices

FDA 510(k) Submission Details - K933335

510(k) Number K933335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1993
Decision Date March 01, 1994
Days to Decision 236 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 129d · This submission: 236d
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 K933335.
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
ADVANTAGE SYRINGE
K941545 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1994
ONE TIME VIAL ACCESS SPIKE
K934561 · Icu Medical, Inc. · Feb 1994
MONOJECT(R) 6 CC SAFETY SYRINGE
K924511 · Sherwood Medical Co. · Jul 1993
FIBRACOL COLLAGEN-ALGINATE DRESSING
K925548 · Johnson & Johnson Medical, Inc. · Jul 1993