Cleared Traditional

K012485 - MS-140 ALL-ROUND ENHANCED PERFORMANCE F...

Also marketed or referenced as:
MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED MS-142 ALL-ROUND/HME ENHANCE

K012485 is an FDA 510(k) clearance for MS-140 ALL-ROUND ENHANCED PERFORMANCE F..., 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 68-day FDA review.

K012485 · King Systems Corp. · General Hospital
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Oct 2001
Decision
68d
Days
Class 2
Risk

K012485 is an FDA 510(k) clearance for the MS-140 ALL-ROUND ENHANCED PERFORMANCE 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 October 9, 2001 after a review of 68 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 - K012485

510(k) Number K012485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 2001
Decision Date October 09, 2001
Days to Decision 68 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
61d faster than avg
Panel avg: 129d · This submission: 68d
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 K012485.
TERUMO GAS FILTER
K021020 · Terumo Cardiovascular Systems Corp. · Jun 2002
EMS ELECTROSTATIC FLITER AND HME COMBINATION
K013122 · Engineered Medical Systems · Apr 2002
EMS HEPA FILTER AND HME COMBINATIONS
K013089 · Engineered Medical Systems · Mar 2002
END EXPIRATORY FILTER, MODEL RT020
K002839 · Fisher &Paykel Healthcare , Ltd. · Oct 2001
AIRLIFE HEPA FILTER
K011132 · Allegiance Healthcare Corp. · Jun 2001
SLEEVED FILTER
K010040 · King Systems Corp. · Mar 2001