Cleared Traditional

K896333 - CMS IV FILTERS

K896333 is an FDA 510(k) clearance for CMS IV FILTERS, manufactured by Churchill Medical Systems, Inc.. The device is a Class 2 General Hospital device with product code FPB cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K896333 · Churchill Medical Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1990
Decision
69d
Days
Class 2
Risk

K896333 is an FDA 510(k) clearance for the CMS IV FILTERS. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Churchill Medical Systems, Inc. (Horsham, US). The FDA issued a Cleared decision on January 11, 1990 after a review of 69 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.

FDA 510(k) Submission Details - K896333

510(k) Number K896333 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1989
Decision Date January 11, 1990
Days to Decision 69 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
60d faster than avg
Panel avg: 129d · This submission: 69d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPB Device Classification - Class 2, Special Controls

Product Code FPB Filter, Infusion Line
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 - FPB Filter, Infusion Line

All 87
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K896333.
I.V. FILTER EXTENSION SET
K912848 · Filtertek, Inc. · Nov 1991
PALL 3N1 FILTER
K905794 · Pall Biomedical Products Co. · Jun 1991
I.V. EXTENDER SET
K911451 · Filtertek, Inc. · Jun 1991
1.2 MICRON FILTER WITH IV SET
K896292 · Kendall Mcgaw Laboratories, Inc. · Dec 1989
.22 & 1.2 MICRON IV FILTERS
K894954 · Churchill Medical Systems, Inc. · Nov 1989
LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER
K880605 · Miles Laboratories, Inc. · May 1988
K896333 · CMS IV FILTERS
Download PDF Churchill Medical Sys…