Cleared Traditional

K781978 - PUNCTURE KIT

K781978 is an FDA 510(k) clearance for PUNCTURE KIT, manufactured by Arrow Intl., Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K781978 · Arrow Intl., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1978
Decision
15d
Days
Class 2
Risk

K781978 is an FDA 510(k) clearance for the PUNCTURE KIT, DISPOSALBE VEIN. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Walker, US). The FDA issued a Cleared decision on December 12, 1978 after a review of 15 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 Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K781978

510(k) Number K781978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1978
Decision Date December 12, 1978
Days to Decision 15 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
114d faster than avg
Panel avg: 129d · This submission: 15d
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 315
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K781978.
CONTROL SYRINGE
K801430 · Abco Dealers, Inc. · Jul 1980
BURRON MULTI-AD SYRINGE CAP
K801311 · Burron Medical Products, Inc. · Jun 1980
DYNACOR STERILE BLOOD GAS SPECIMEN TRAY
K792033 · Medline Industries, Inc. · Nov 1979
SYRINGE, INSULIN, HYPOTIP
K781154 · National Patent Development Corp. · Aug 1978
STERILE AIR SYRINGE
K780550 · National Patent Development Corp. · Apr 1978
MINI-IRRIGATION TRAY
K780595 · Abco Dealers, Inc. · Apr 1978