Cleared Traditional

K861626 - CHURCHILL EXTENSION TUBE

K861626 is an FDA 510(k) clearance for CHURCHILL EXTENSION TUBE, manufactured by Churchill Corp.. The device is a Class 2 General Hospital device with product code FPK cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K861626 · Churchill Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1986
Decision
41d
Days
Class 2
Risk

K861626 is an FDA 510(k) clearance for the CHURCHILL EXTENSION TUBE. Classified as Tubing, Fluid Delivery (product code FPK), Class II - Special Controls.

Submitted by Churchill Corp. (Langhorne, US). The FDA issued a Cleared decision on June 2, 1986 after a review of 41 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.

View all Churchill Corp. devices

FDA 510(k) Submission Details - K861626

510(k) Number K861626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1986
Decision Date June 02, 1986
Days to Decision 41 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
88d faster than avg
Panel avg: 129d · This submission: 41d
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 22
Devices cleared under the same product code (FPK) and FDA review panel - the closest regulatory comparables to K861626.
MERIT HI-FLEX(TM)
K883718 · Merit Medical Systems, Inc. · Jan 1989
INFUSION MANIFOLD
K873852 · Advanced Surgical Products, Inc. · Nov 1987
EXTENSION TUBE PUMP SET
K871085 · Churchill Corp. · Jun 1987
CHURCHILL-H EXTENSION TUBE
K854629 · Churchill Corp. · Dec 1985
C-FLEX MEDICAL GRADE TUBING
K833076 · Concept, Inc. · Nov 1983
SAFEED EXTENSION TUBES
K810005 · Terumo Medical Corp. · Feb 1981