Cleared Traditional

K010040 - SLEEVED FILTER

K010040 is an FDA 510(k) clearance for SLEEVED FILTER, manufactured by King Systems Corp.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K010040 · King Systems Corp. · General Hospital
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Mar 2001
Decision
63d
Days
Class 2
Risk

K010040 is an FDA 510(k) clearance for the SLEEVED FILTER. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by King Systems Corp. (Noblesville, US). The FDA issued a Cleared decision on March 9, 2001 after a review of 63 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.5260 - 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 King Systems Corp. devices

FDA 510(k) Submission Details - K010040

510(k) Number K010040 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2001
Decision Date March 09, 2001
Days to Decision 63 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 129d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAH Device Classification - Class 2, Special Controls

Product Code CAH Filter, Bacterial, Breathing-circuit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5260
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 - CAH Filter, Bacterial, Breathing-circuit

All 103
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K010040.
MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER
K012485 · King Systems Corp. · Oct 2001
END EXPIRATORY FILTER, MODEL RT020
K002839 · Fisher &Paykel Healthcare , Ltd. · Oct 2001
AIRLIFE HEPA FILTER
K011132 · Allegiance Healthcare Corp. · Jun 2001
CLEAR-GUARD II, CLEAR-THERM HMEF, CLEAR-THERM HMEF W/ FLEXTUBE, CLEAR GUARD 11 W/ GAS MONITORING PORT
K990949 · Intersurgical, Inc. · Jun 1999
CLEAR-GUARD MIDI, CLEAR-GUARD MIDI W/FLEXTUBE, CLEAR-THERM MINI, CLEAR-THERM MINI W/FLEXTUBE, MODELS 1644,1644-T,1831,18
K983610 · Intersurgical, Inc. · Apr 1999
BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F)
K983817 · King Systems Corp. · Mar 1999