Cleared Traditional

K961251 - PUNCTUR-GUARD WINGED SET

K961251 is an FDA 510(k) clearance for PUNCTUR-GUARD WINGED SET, manufactured by Bio-Plexus, Inc.. The device is a Class 2 General Hospital device with product code FMI cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K961251 · Bio-Plexus, Inc. · General Hospital
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Jun 1996
Decision
87d
Days
Class 2
Risk

K961251 is an FDA 510(k) clearance for the PUNCTUR-GUARD WINGED SET. Classified as Needle, Hypodermic, Single Lumen (product code FMI), Class II - Special Controls.

Submitted by Bio-Plexus, Inc. (Tolland, US). The FDA issued a Cleared decision on June 27, 1996 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 880.5570 - 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.

View all Bio-Plexus, Inc. devices

FDA 510(k) Submission Details - K961251

510(k) Number K961251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 1996
Decision Date June 27, 1996
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.

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 442
Devices cleared under the same product code (FMI) and FDA review panel - the closest regulatory comparables to K961251.
PISTON SYRINGE
K961877 · Univec, Inc. · Aug 1996
CLINICARE STERILE DISPOSABLE SYRINGE/NEEDLES
K955772 · Ttk Biomed, Ltd. · Jul 1996
NON-CORING NEEDLE
K961088 · Arrow Intl., Inc. · Jul 1996
SHARPS-TAINER
K961878 · Winfield Industries · Jun 1996
GE STERILE ARTHROGRAM TRAY
K962035 · GE Medical Systems · Jun 1996
RNS ARTHROGRAM TRAY
K962040 · Contour Fabricators of Florida, Inc. · Jun 1996