Cleared Traditional

K090122 - NUOVOGUARD

K090122 is an FDA 510(k) clearance for NUOVOGUARD, manufactured by U.S. Safety Syringes Co., Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K090122 · U.S. Safety Syringes Co., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
15d
Days
Class 2
Risk

K090122 is an FDA 510(k) clearance for the NUOVOGUARD. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by U.S. Safety Syringes Co., Inc. (Crofton, US). The FDA issued a Cleared decision on February 5, 2009 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 880.5200 - 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 U.S. Safety Syringes Co., Inc. devices

FDA 510(k) Submission Details - K090122

510(k) Number K090122 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 2009
Decision Date February 05, 2009
Days to Decision 15 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
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. Third-party reviewed.

FOZ Device Classification - Class 2, Special Controls

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 352
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K090122.
TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)
K090973 · Terumo Corp. · May 2009
TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER
K082997 · Terumo Medical Corp. · Apr 2009
SUPERCATH 5
K081953 · Togo Medikit Co., Ltd. · Mar 2009
SURSHIELD SAFETY I.V. CATHETER
K082362 · Terumo Medical Corp. · Sep 2008
COOK AND COOK SPECTRUM CENTRAL VENOUS CATHETERS
K081113 · Cook, Inc. · Jul 2008
SPECTRUM TURBO-JECT PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER
K081690 · Cook, Inc. · Jul 2008