Cleared Traditional

I.V. CATHETER (K772354) - FDA 510(k) Clearance

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

K772354 · Ndm Corp. · General Hospital
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Jan 1978
Decision
35d
Days
Class 2
Risk

K772354 is an FDA 510(k) clearance for the I.V. CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Ndm Corp. (Mchenry, US). The FDA issued a Cleared decision on January 31, 1978 after a review of 35 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 Ndm Corp. devices

Submission Details

510(k) Number K772354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1977
Decision Date January 31, 1978
Days to Decision 35 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
94d faster than avg
Panel avg: 129d · This submission: 35d
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 110
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K772354.
WHOLEY OCCLUSION BALLOON CATHETER
K772011 · Cook, Inc. · Jun 1979
I.V. START KIT
K780350 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Mar 1978
NEEDLE CONNECTING SET, BLUNT
K780105 · Abbott Laboratories · Feb 1978
CATHETER-THRU-NEEDLE DEVICE
K770403 · Abbott Laboratories · Mar 1977