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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FMF Syringe, Piston

All 751
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K072318.
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
POWRSYRINGE ASPIRATOR
K072299 · Pinyons Medical Technology, Inc. · Oct 2007
POWRSYRINGE MONITOR
K072345 · Pinyons Medical Technology, Inc. · Sep 2007
SMALL VOLUME SYRINGE
K062865 · Alcon Laboratories · Aug 2007
CRYOSEAL FS APPLICATOR SYSTEM
K071126 · Thermogenesis Corp. · Aug 2007

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K072318 · POWRSYRINGE INJECTOR
Download PDF FDA Summary Pinyons Medical Techn…