Cleared Traditional

K083454 - NUOVOCATH

K083454 is an FDA 510(k) clearance for NUOVOCATH, 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 13-day FDA review.

K083454 · U.S. Safety Syringes Co., Inc. · General Hospital
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Dec 2008
Decision
13d
Days
Class 2
Risk

K083454 is an FDA 510(k) clearance for the NUOVOCATH. 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 December 4, 2008 after a review of 13 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.

FDA 510(k) Submission Details - K083454

510(k) Number K083454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2008
Decision Date December 04, 2008
Days to Decision 13 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 129d · This submission: 13d
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 Consultant

Underwriters Laboratories, Inc.
NED DEVINE

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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 473
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K083454.
SUPERCATH 5
K081953 · Togo Medikit Co., Ltd. · Mar 2009
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K090502 · U.S. Safety Syringes Co., Inc. · Mar 2009
NUOVOGUARD
K090122 · U.S. Safety Syringes Co., Inc. · Feb 2009
VANISHPOINT I.V. CATHETER
K081420 · Retractable Technologies, Inc. · Nov 2008
FIRMGRIP
K080793 · Flexicath , Ltd. · Oct 2008
SURSHIELD SAFETY I.V. CATHETER
K082362 · Terumo Medical Corp. · Sep 2008

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.

K083454 · NUOVOCATH
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