Cleared Traditional

K032247 - U.S. TECHNOLOGIES, INC. RETRACTABLE SAFETY SYRINGE

K032247 is an FDA 510(k) clearance for U.S. TECHNOLOGIES, manufactured by U.S. Technologies, Inc.. The device is a Class 2 General Hospital device with product code MEG cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K032247 · U.S. Technologies, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
70d
Days
Class 2
Risk

K032247 is an FDA 510(k) clearance for the U.S. TECHNOLOGIES, INC. RETRACTABLE SAFETY SYRINGE. Classified as Syringe, Antistick (product code MEG), Class II - Special Controls.

Submitted by U.S. Technologies, Inc. (North Attleboro, US). The FDA issued a Cleared decision on September 30, 2003 after a review of 70 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 - K032247

510(k) Number K032247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 2003
Decision Date September 30, 2003
Days to Decision 70 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
59d faster than avg
Panel avg: 129d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MEG Device Classification - Class 2, Special Controls

Product Code MEG Syringe, Antistick
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 - MEG Syringe, Antistick

All 162
Devices cleared under the same product code (MEG) and FDA review panel - the closest regulatory comparables to K032247.
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K032247 · U.S. TECHNOLOGIES, INC. RETRACTABLE SAFETY SYRINGE
Download PDF FDA Summary U.S. Technologies, In…