Cleared Traditional

K082997 - TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER

K082997 is an FDA 510(k) clearance for TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V...., manufactured by Terumo Medical Corp.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K082997 · Terumo Medical Corp. · General Hospital
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Optimized for regulatory review, auditing and printing
Apr 2009
Decision
189d
Days
Class 2
Risk

K082997 is an FDA 510(k) clearance for the TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on April 15, 2009 after a review of 189 days - an extended review 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: 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.

View all Terumo Medical Corp. devices

FDA 510(k) Submission Details - K082997

510(k) Number K082997 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 2008
Decision Date April 15, 2009
Days to Decision 189 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
60d slower than avg
Panel avg: 129d · This submission: 189d
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

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

All 430
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K082997.
SNM FIRMGRIP
K092629 · Flexicath , Ltd. · Sep 2009
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K083429 · Weihai Jierui Medical Products Co., Ltd. · Aug 2009
TERUMO SURSHIELD SAFETY I.V. CATHETER (18G X 51MM & 20G X 51MM SIZES)
K090973 · Terumo Corp. · May 2009
SUPERCATH 5
K081953 · Togo Medikit Co., Ltd. · Mar 2009
NOVA SAFE SCALP VEIN BLOOD COLLECTION SET
K090502 · U.S. Safety Syringes Co., Inc. · Mar 2009
NUOVOGUARD
K090122 · U.S. Safety Syringes Co., Inc. · Feb 2009

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.