Cleared Traditional

K781127 - CONNECTING TUBE

K781127 is the FDA 510(k) clearance for CONNECTING TUBE by Seamless Hospital Products Co.. It is a Class 2 General Hospital device (product code GAZ) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K781127 · Seamless Hospital Products Co. · General Hospital
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Sep 1978
Decision
77d
Days
Class 2
Risk

K781127 is an FDA 510(k) clearance for the CONNECTING TUBE, CONDUCTIVE, SURG.. Classified as Tubing, Noninvasive (product code GAZ), Class II - Special Controls.

Submitted by Seamless Hospital Products Co. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1978 after a review of 77 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 Seamless Hospital Products Co. devices

Submission Details

510(k) Number K781127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1978
Decision Date September 20, 1978
Days to Decision 77 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
52d faster than avg
Panel avg: 129d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 12
Devices cleared under the same product code (GAZ) and FDA review panel - the closest regulatory comparables to K781127.
LATEX PENROSE TUBING CAT. #20400,414,416
K802761 · American Hospital Supply Corp. · Nov 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
THORACIC DRAINAGE SET, ARGYLE DUAL
K770920 · Sherwood Medical Industries · Jun 1977