Cleared Traditional

K780673 - CENTRAL CATHETER KIT

K780673 is an FDA 510(k) clearance for CENTRAL CATHETER KIT, manufactured by Argon Medical Corp.. The device is a Class 2 General Hospital device with product code FPK cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K780673 · Argon Medical Corp. · General Hospital
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May 1978
Decision
22d
Days
Class 2
Risk

K780673 is an FDA 510(k) clearance for the CENTRAL CATHETER KIT. Classified as Tubing, Fluid Delivery (product code FPK), Class II - Special Controls.

Submitted by Argon Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on May 16, 1978 after a review of 22 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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.

FDA 510(k) Submission Details - K780673

510(k) Number K780673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1978
Decision Date May 16, 1978
Days to Decision 22 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
107d faster than avg
Panel avg: 129d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPK Device Classification - Class 2, Special Controls

Product Code FPK Tubing, Fluid Delivery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPK Tubing, Fluid Delivery

All 63
Devices cleared under the same product code (FPK) and FDA review panel - the closest regulatory comparables to K780673.
CLEAR PLASTIC CONNECTING TUBES
K800879 · Harvard Laboratories · Jun 1980
EXTENSION SET QUEST CODE #3000
K800825 · Quest Medical, Inc. · May 1980
MEDICAL GRADE SILICONE ELASTOMER TUBING
K781087 · Mcghan Medical Corp. · Nov 1978
NASAL GASTRIC TUBE RETAINER
K780396 · Mor-Mac, Inc. · Mar 1978
TIME WATCH
K772119 · Akzona, Inc. · Nov 1977
BLOOD COLLECTION SET TYPE H
K771269 · Berman, Pcp & Consultants, Inc. · Sep 1977
K780673 · CENTRAL CATHETER KIT
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