Cleared Traditional

K861644 - CRITIKON 48-HOUR AIR ELIMINATING FILTER

K861644 is an FDA 510(k) clearance for CRITIKON 48-HOUR AIR ELIMINATING FILTER, manufactured by Critikon Company, LLC. The device is a Class 2 General Hospital device with product code FPB cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K861644 · Critikon Company, LLC · General Hospital
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Jul 1986
Decision
83d
Days
Class 2
Risk

K861644 is an FDA 510(k) clearance for the CRITIKON 48-HOUR AIR ELIMINATING FILTER. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Critikon Company, LLC (Tampa, US). The FDA issued a Cleared decision on July 22, 1986 after a review of 83 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 Critikon Company, LLC devices

FDA 510(k) Submission Details - K861644

510(k) Number K861644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 1986
Decision Date July 22, 1986
Days to Decision 83 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
46d faster than avg
Panel avg: 129d · This submission: 83d
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 66
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K861644.
CHURCHILL 1.2 MICRON LIQUID FILTER SET
K880027 · Churchill Corp. · Apr 1988
CUTTER PUREFLO PLUS IV FILTER
K872634 · Miles Laboratories, Inc. · Aug 1987
CONTINU-FLO SOLUTION ADMIN. SET W/IN-LINE FILTER
K865029 · Travenol Laboratories, S.A. · Apr 1987
IV FILTER EXTENSION SET
K860803 · Med Fusion Systems, Inc. · Apr 1986
AUTO SYRINGE MICRO VOL EXT SET W/AIR VENT FILTER
K860746 · Travenol Laboratories, S.A. · Apr 1986
PREVENT 0.2 MICRON IV FILTER W/VENT & EXTENSION SE
K855065 · Cobe Laboratories, Inc. · Feb 1986