Cleared Traditional

K884370 - CMS IV EXTENSION SETS

K884370 is an FDA 510(k) clearance for CMS IV EXTENSION SETS, manufactured by Churchill Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code FPK cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K884370 · Churchill Medical Systems, Inc. · General Hospital
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Nov 1988
Decision
20d
Days
Class 2
Risk

K884370 is an FDA 510(k) clearance for the CMS IV EXTENSION SETS. Classified as Tubing, Fluid Delivery (product code FPK), Class II - Special Controls.

Submitted by Churchill Medical Systems, Inc. (Horsham, US). The FDA issued a Cleared decision on November 7, 1988 after a review of 20 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 Medical Systems, Inc. devices

FDA 510(k) Submission Details - K884370

510(k) Number K884370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1988
Decision Date November 07, 1988
Days to Decision 20 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
109d faster than avg
Panel avg: 129d · This submission: 20d
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 29
Devices cleared under the same product code (FPK) and FDA review panel - the closest regulatory comparables to K884370.
INTRAVASCULAR ADMINI. SET MODELS 60030 & 60050
K891005 · 3M Company · May 1989
MERIT HI-FLEX(TM)
K883718 · Merit Medical Systems, Inc. · Jan 1989
HYPERBARIC INTRAVENOUS INFUSION EXTENSION SET
K884156 · Sechrist Industries, Inc. · Nov 1988
IV EXTENSION SET
K875186 · Marquette Medical, Inc. · Feb 1988
INFUSION MANIFOLD
K873852 · Advanced Surgical Products, Inc. · Nov 1987
EXTENSION TUBE PUMP SET
K871085 · Churchill Corp. · Jun 1987