Cleared Traditional

K946190 - DRUG DISPENSING SPIKE

K946190 is an FDA 510(k) clearance for DRUG DISPENSING SPIKE, 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 87-day FDA review.

K946190 · Gelman Sciences, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
87d
Days
Class 2
Risk

K946190 is an FDA 510(k) clearance for the DRUG DISPENSING SPIKE. 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 March 17, 1995 after a review of 87 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 Gelman Sciences, Inc. devices

FDA 510(k) Submission Details - K946190

510(k) Number K946190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1994
Decision Date March 17, 1995
Days to Decision 87 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
42d faster than avg
Panel avg: 129d · This submission: 87d
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 K946190.
PTFE SYRINGE FILTER
K952918 · B.Braun Medical, Inc. · Sep 1995
STRYKER DROP APPLICATOR, KITS, SPRAY APPLICATOR KIT, TIPS
K950824 · Stryker Corp. · Aug 1995
SURGICAL TECHNOLOGIES, INC. SYRINGE
K951918 · Surgical Technologies, Inc. · Jul 1995
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