Cleared Traditional

K961877 - PISTON SYRINGE

K961877 is an FDA 510(k) clearance for PISTON SYRINGE, manufactured by Univec, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K961877 · Univec, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1996
Decision
89d
Days
Class 2
Risk

K961877 is an FDA 510(k) clearance for the PISTON SYRINGE. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Univec, Inc. (Garden City, US). The FDA issued a Cleared decision on August 7, 1996 after a review of 89 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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.

FDA 510(k) Submission Details - K961877

510(k) Number K961877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1996
Decision Date August 07, 1996
Days to Decision 89 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
40d faster than avg
Panel avg: 129d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FMI Device Classification - Class 2, Special Controls

Product Code FMI Needle, Hypodermic, Single Lumen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
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 - FMI Needle, Hypodermic, Single Lumen

All 635
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K961877.
I.V. START KIT
K950686 · James J. Schramm · Oct 1996
SAFETY CRADLE
K962149 · Specialized Health Products, Inc. · Oct 1996
BIO-PLEXUS NEEDLE DISPOSAL CONTAINER
K960933 · Bio-Plexus, Inc. · Aug 1996
CLINICARE STERILE DISPOSABLE SYRINGE/NEEDLES
K955772 · Ttk Biomed, Ltd. · Jul 1996
NON-CORING NEEDLE
K961088 · Arrow Intl., Inc. · Jul 1996
PUNCTUR-GUARD WINGED SET
K961251 · Bio-Plexus, Inc. · Jun 1996
K961877 · PISTON SYRINGE
Download PDF FDA Summary Univec, Inc.