Cleared Traditional

K802761 - LATEX PENROSE TUBING CAT. #20400,414,416

K802761 is an FDA 510(k) clearance for LATEX PENROSE TUBING CAT. #20400, manufactured by American Hospital Supply Corp.. The device is a Class 2 General Hospital device with product code GAZ cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K802761 · American Hospital Supply Corp. · General Hospital
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Nov 1980
Decision
15d
Days
Class 2
Risk

K802761 is an FDA 510(k) clearance for the LATEX PENROSE TUBING CAT. #20400,414,416. Classified as Tubing, Noninvasive (product code GAZ), Class II - Special Controls.

Submitted by American Hospital Supply Corp. (Mchenry, US). The FDA issued a Cleared decision on November 19, 1980 after a review of 15 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - 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 American Hospital Supply Corp. devices

FDA 510(k) Submission Details - K802761

510(k) Number K802761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1980
Decision Date November 19, 1980
Days to Decision 15 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
114d faster than avg
Panel avg: 129d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GAZ Device Classification - Class 2, Special Controls

Product Code GAZ Tubing, Noninvasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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 - GAZ Tubing, Noninvasive

All 15
Devices cleared under the same product code (GAZ) and FDA review panel - the closest regulatory comparables to K802761.
STERILE SAFETY PINS
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PLEUROFIX THORACENTESIS KIT
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ARGYLE CONNECT TUBE-CON & NON
K802777 · Sherwood Medical Co. · Dec 1980
FLUID ADMINISTRATION CAT.#14-923
K790358 · Norton Performance Plastics Corp. · Mar 1979
FILTER SYSTEM, ALTNER DISPOSABLE
K790209 · Orthopedic Equipment Co., Inc. · Feb 1979
PVC LINES FOR MONITORING
K780985 · Norton Performance Plastics Corp. · Jul 1978