Cleared Traditional

K941020 - DRUG RECONSTITUTION FILTER DEVICE

K941020 is an FDA 510(k) clearance for DRUG RECONSTITUTION FILTER DEVICE, manufactured by Gelman Sciences, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K941020 · Gelman Sciences, Inc. · General Hospital
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Aug 1994
Decision
160d
Days
Class 2
Risk

K941020 is an FDA 510(k) clearance for the DRUG RECONSTITUTION FILTER DEVICE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Gelman Sciences, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on August 10, 1994 after a review of 160 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 Gelman Sciences, Inc. devices

FDA 510(k) Submission Details - K941020

510(k) Number K941020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 1994
Decision Date August 10, 1994
Days to Decision 160 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 129d · This submission: 160d
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 492
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K941020.
MONOJECT(R) PISTON SYRINGES
K945715 · Sherwood Medical Co. · Mar 1995
DISPOSABLE 1CC SYRINGE WITH LUER LOCK
K945588 · Interventional Therapeutics Corp. · Feb 1995
SYRINGE FILTER DEVICES
K941589 · Gelman Sciences, Inc. · Sep 1994
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