Cleared Traditional

K851142 - TELET-LEX MEDICAL IV CATHETER PLACEMENT

K851142 is the FDA 510(k) clearance for TELET-LEX MEDICAL IV CATHETER PLACEMENT by Teleflexmedical, Inc.. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K851142 · Teleflexmedical, Inc. · General Hospital
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Jul 1985
Decision
106d
Days
Class 2
Risk

K851142 is an FDA 510(k) clearance for the TELET-LEX MEDICAL IV CATHETER PLACEMENT. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Teleflexmedical, Inc. (Jeffrey, US). The FDA issued a Cleared decision on July 5, 1985 after a review of 106 days - within the typical 510(k) review window.

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 Teleflexmedical, Inc. devices

Submission Details

510(k) Number K851142 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1985
Decision Date July 05, 1985
Days to Decision 106 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
23d faster than avg
Panel avg: 129d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 240
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K851142.
VIAPIC CENTRAL LINE CATHETER
K860290 · Parke-Davis Co. · Mar 1986
TERUMO SURFLO ETFE I.V. CATHETER
K854566 · Terumo Medical Corp. · Jan 1986
JELCO & CATHLON IV STRIPED IV CATHETERS-RADIOPAGUL
K853701 · Critikon Company, LLC · Oct 1985
DESERET ARTERIAL CATHETER
K851327 · Parke-Davis Co. · Jun 1985
SPECTRUM(TENTATIVE)
K852078 · Parke-Davis Co. · Jun 1985
QUINTON INJECTION SEALING CAP
K844193 · Quinton, Inc. · May 1985