Cleared Traditional

K033739 - PHYSICIAN INDUSTRIES' DURAMETER SYRINGE

K033739 is an FDA 510(k) clearance for PHYSICIAN INDUSTRIES' DURAMETER SYRINGE, manufactured by Physician Industries, Inc.. The device is a Class 2 General Hospital device with product code FMF cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K033739 · Physician Industries, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
227d
Days
Class 2
Risk

K033739 is an FDA 510(k) clearance for the PHYSICIAN INDUSTRIES' DURAMETER SYRINGE. Classified as Syringe, Piston (product code FMF), Class II - Special Controls.

Submitted by Physician Industries, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on July 12, 2004 after a review of 227 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K033739

510(k) Number K033739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2003
Decision Date July 12, 2004
Days to Decision 227 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
98d slower than avg
Panel avg: 129d · This submission: 227d
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 686
Devices cleared under the same product code (FMF) and FDA review panel - the closest regulatory comparables to K033739.
HEMAMYST SURGICAL APPLICATOR SYSTEM, MODEL H-AS01
K041504 · Haemacure Corp. · Aug 2004
OPEN BORE SYRINGE
K041344 · Isotis NV · Jul 2004
CLIP-ON SPACER 20%
K041084 · Serono, Inc. · Jul 2004
AUTODETECT SYRINGE
K041590 · Indigo Orb, Inc. · Jun 2004
VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT
K033721 · Vascular Solutions, Inc. · Feb 2004
ULTICARE DISPOSABLE SYRINGE 3 ML/CC
K033794 · Ultimed, Inc. · Dec 2003
K033739 · PHYSICIAN INDUSTRIES' DURAMETER SYRINGE
Download PDF FDA Summary Physician Industries,…