Cleared Traditional

K864103 - CURITY ANESTHESIA FILTER

K864103 is an FDA 510(k) clearance for CURITY ANESTHESIA FILTER, manufactured by The Kendal Co.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K864103 · The Kendal Co. · General Hospital
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Jan 1987
Decision
99d
Days
Class 2
Risk

K864103 is an FDA 510(k) clearance for the CURITY ANESTHESIA FILTER. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by The Kendal Co. (Boston, US). The FDA issued a Cleared decision on January 28, 1987 after a review of 99 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all The Kendal Co. devices

FDA 510(k) Submission Details - K864103

510(k) Number K864103 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1986
Decision Date January 28, 1987
Days to Decision 99 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
30d faster than avg
Panel avg: 129d · This submission: 99d
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 79
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K864103.
OMNIFILTER MAIN FLOW BACTERIA FILTER
K890362 · Puritan Bennett Corp. · Mar 1989
RESUSCITATION BAG EXHALATION FILTER
K883693 · Intertech Resources, Inc. · Sep 1988
SIEMENS MAIN FLOW BACTERIA FILTER
K871366 · Siemens Elema AB · May 1987
MP-1204 DISPOSABLE BACTERIA FILTER
K862785 · Medipart Jerry Alexander · Aug 1986
MP-50T DISPOSABLE BREATHING CIRCUIT FILTER
K862786 · Medipart Jerry Alexander · Aug 1986
MP-2831 DISPOSABLE CONDUCTIVE BREATHING FILTER
K862787 · Medipart Jerry Alexander · Aug 1986