Cleared Traditional

K854629 - CHURCHILL-H EXTENSION TUBE

K854629 is the FDA 510(k) clearance for CHURCHILL-H EXTENSION TUBE by Churchill Corp.. It is a Class 2 General Hospital device (product code FPK) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K854629 · Churchill Corp. · General Hospital
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Dec 1985
Decision
22d
Days
Class 2
Risk

K854629 is an FDA 510(k) clearance for the CHURCHILL-H 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 December 10, 1985 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.

View all Churchill Corp. devices

Submission Details

510(k) Number K854629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 1985
Decision Date December 10, 1985
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.

Device Classification

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 20
Devices cleared under the same product code (FPK) and FDA review panel - the closest regulatory comparables to K854629.
INFUSION MANIFOLD
K873852 · Advanced Surgical Products, Inc. · Nov 1987
EXTENSION TUBE PUMP SET
K871085 · Churchill Corp. · Jun 1987
CHURCHILL EXTENSION TUBE
K861626 · Churchill Corp. · Jun 1986
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