Cleared Traditional

K813396 - VERSCHLUBSTOPFEN COMB-CLOSING STOPPER

K813396 is an FDA 510(k) clearance for VERSCHLUBSTOPFEN COMB-CLOSING STOPPER, manufactured by Burron Medical Products, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K813396 · Burron Medical Products, Inc. · General Hospital
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Jan 1982
Decision
39d
Days
Class 2
Risk

K813396 is an FDA 510(k) clearance for the VERSCHLUBSTOPFEN COMB-CLOSING STOPPER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Burron Medical Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 12, 1982 after a review of 39 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 Burron Medical Products, Inc. devices

FDA 510(k) Submission Details - K813396

510(k) Number K813396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1981
Decision Date January 12, 1982
Days to Decision 39 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 129d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 344
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K813396.
DESERET INTRACATH INTRAVENOUS CATHETER
K821372 · Warner-Lambert Co. · Jun 1982
NUTRICATH
K813374 · Exco, Inc. · Mar 1982
CRITIKON I.V. CATHETER PLACEMENT UNIT
K813345 · Critikon Company, LLC · Jan 1982
B-D HEPARINIZED LONGDWEL I.V. CATHETER
K812137 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1981
INTRAVASCULAR CATHETER
K803238 · G.D. Searle and Co. · Apr 1981
BURRON MICROCATH INTRA. CATH. PLACEMENTT
K801941 · Burron Medical Products, Inc. · Aug 1980