Cleared Traditional

K882335 - DISPOSABLE SYRINGE

K882335 is the FDA 510(k) clearance for DISPOSABLE SYRINGE by Baxter Healthcare Corp. It is a Class 2 General Hospital device (product code FMF) cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K882335 · Baxter Healthcare Corp · General Hospital
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Jun 1988
Decision
10d
Days
Class 2
Risk

K882335 is an FDA 510(k) clearance for the DISPOSABLE SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on June 16, 1988 after a review of 10 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K882335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1988
Decision Date June 16, 1988
Days to Decision 10 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 129d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 296
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K882335.
BD MICROFINE IV PEN INJECTOR
K881775 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1988
MX350 (SERIES) CONTROL SYRINGE
K883094 · Medex, Inc. · Aug 1988
HAC AUTOLOGY CENTERS DISPENSING KIT FOR FIB.CON.
K880963 · Buckman Co., Inc. · Jun 1988
MEDSURG MYELOGRAM TRAY
K880693 · Medsurg Industries, Inc. · May 1988
ALLERGIST SYRINGES
K880894 · Abco Dealers, Inc. · Mar 1988
SAFETY SYRINGE
K872820 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1987