Cleared Special

DUPLOGRIP (K003193) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K003193 · Baxter Healthcare Corp · General Hospital
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Nov 2000
Decision
26d
Days
Class 2
Risk

K003193 is an FDA 510(k) clearance for the DUPLOGRIP. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Glendale, US). The FDA issued a Cleared decision on November 7, 2000 after a review of 26 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Baxter Healthcare Corp devices

Submission Details

510(k) Number K003193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 2000
Decision Date November 07, 2000
Days to Decision 26 days
Submission Type Special
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
103d faster than avg
Panel avg: 129d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 207
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K003193.
DUPLOJECT EASY-PREP SYSTEM 1ML, 2ML, 5ML
K020666 · Baxter Healthcare Corp · Jun 2002
DUPLOREACH
K014088 · Baxter Healthcare Corp · Jun 2002
STERILE PISTON SYRINGE
K002717 · Abbott Laboratories · Jan 2001
TISSOMAT AND SPRAY SET
K981089 · Baxter Healthcare Corp · Jul 2000
VACLOK SYRINGE
K994253 · Merit Medical Systems, Inc. · Jan 2000
STERILE WATER FOR INJECTION PREFILLED SYRING (SWFIPS)
K972728 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jul 1998