Cleared Traditional

INTRAVENOUS CATHETER PLACEMENT UNIT & (K823017) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K823017 · Access Devices, Inc. · General Hospital
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Nov 1982
Decision
19d
Days
Class 2
Risk

K823017 is an FDA 510(k) clearance for the INTRAVENOUS CATHETER PLACEMENT UNIT &. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Access Devices, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 1, 1982 after a review of 19 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 Access Devices, Inc. devices

Submission Details

510(k) Number K823017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1982
Decision Date November 01, 1982
Days to Decision 19 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 129d · This submission: 19d
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 128
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K823017.
INJECTION CAP
K834480 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1984
INJECTION SEALING CAP 13791
K830541 · Quinton, Inc. · Aug 1983
WINGED CATHETER
K830765 · Abbott Laboratories · Mar 1983
B-D HEPARINIZED LONGDWEL I.V. CATHETER
K812137 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1981
WHOLEY OCCLUSION BALLOON CATHETER
K772011 · Cook, Inc. · Jun 1979
I.V. START KIT
K780350 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1978