Cleared Traditional

K072318 - POWRSYRINGE INJECTOR

K072318 is an FDA 510(k) clearance for POWRSYRINGE INJECTOR, manufactured by Pinyons Medical Technology, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K072318 · Pinyons Medical Technology, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Sep 2007
Decision
32d
Days
Class 2
Risk

K072318 is an FDA 510(k) clearance for the POWRSYRINGE INJECTOR. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Pinyons Medical Technology, Inc. (Park City, US). The FDA issued a Cleared decision on September 21, 2007 after a review of 32 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 Pinyons Medical Technology, Inc. devices

FDA 510(k) Submission Details - K072318

510(k) Number K072318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2007
Decision Date September 21, 2007
Days to Decision 32 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 129d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 388
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K072318.
UNIVERSAL VIAL ACCESS SPIKE
K080989 · Icu Medical, Inc. · May 2008
CONTROLLED DELIVERY FOR OSTEOPLASTY (CDO SYSTEM) AND GRAFT PREPARATION SYSTEM
K072330 · Biomet, Inc. · Dec 2007
ICU MEDICAL SINGLE-USE SYRINGE
K070856 · Icu Medical, Inc. · Oct 2007
SMALL VOLUME SYRINGE
K062865 · Alcon Laboratories · Aug 2007
B. BRAUN PISTON SYRINGES AND OMNICAN AND OMNIFIX INSULIN SYRINGES
K071459 · B.Braun Medical, Inc. · Aug 2007
TERUMO 31G THINPRO INSULIN SYRINGE
K071630 · Terumo Medical Corp. · Jul 2007