Cleared Traditional

K800786 - INJECTION SITE

K800786 is the FDA 510(k) clearance for INJECTION SITE by Quest Medical, Inc.. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K800786 · Quest Medical, Inc. · General Hospital
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May 1980
Decision
30d
Days
Class 2
Risk

K800786 is an FDA 510(k) clearance for the INJECTION SITE, CODE NO. 3100. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Quest Medical, Inc. (Walker, US). The FDA issued a Cleared decision on May 8, 1980 after a review of 30 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 Quest Medical, Inc. devices

Submission Details

510(k) Number K800786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1980
Decision Date May 08, 1980
Days to Decision 30 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
99d faster than avg
Panel avg: 129d · This submission: 30d
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 K800786.
INTRAVASCULAR CATHETER
K803238 · G.D. Searle and Co. · Apr 1981
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ERYTHROCATH INTRAVENOUS CATHETER PLA. U.
K801414 · G.D. Searle and Co. · Aug 1980
MEDICAL COMPONENTS IV CATHETER
K800525 · Medical Components, Inc. · Apr 1980
WHOLEY OCCLUSION BALLOON CATHETER
K772011 · Cook, Inc. · Jun 1979
I.V. START KIT
K780350 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1978