Cleared Traditional

K781087 - MEDICAL GRADE SILICONE ELASTOMER TUBING

K781087 is an FDA 510(k) clearance for MEDICAL GRADE SILICONE ELASTOMER TUBING, manufactured by Mcghan Medical Corp.. The device is a Class 2 General Hospital device with product code FPK cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K781087 · Mcghan Medical Corp. · General Hospital
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Nov 1978
Decision
146d
Days
Class 2
Risk

K781087 is an FDA 510(k) clearance for the MEDICAL GRADE SILICONE ELASTOMER TUBING. Classified as Tubing, Fluid Delivery (product code FPK), Class II - Special Controls.

Submitted by Mcghan Medical Corp. (Mchenry, US). The FDA issued a Cleared decision on November 22, 1978 after a review of 146 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Mcghan Medical Corp. devices

FDA 510(k) Submission Details - K781087

510(k) Number K781087 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1978
Decision Date November 22, 1978
Days to Decision 146 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
17d slower than avg
Panel avg: 129d · This submission: 146d
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 31
Devices cleared under the same product code (FPK) and FDA review panel - the closest regulatory comparables to K781087.
C-FLEX MEDICAL GRADE TUBING
K833076 · Concept, Inc. · Nov 1983
SAFEED EXTENSION TUBES
K810005 · Terumo Medical Corp. · Feb 1981
EXTENSION SET QUEST CODE #3000
K800825 · Quest Medical, Inc. · May 1980
CENTRAL CATHETER KIT
K780673 · Argon Medical Corp. · May 1978
MONITORING LINES & FLUID ADMIN.
K771387 · Norton Performance Plastics Corp. · Aug 1977
CONNECTORS
K770596 · Abco Dealers, Inc. · Jun 1977