Cleared Traditional

K982239 - CIRCUIT GUARD

K982239 is an FDA 510(k) clearance for CIRCUIT GUARD, manufactured by Arc Medical, Inc.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K982239 · Arc Medical, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
52d
Days
Class 2
Risk

K982239 is an FDA 510(k) clearance for the CIRCUIT GUARD. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Arc Medical, Inc. (Scottdale, US). The FDA issued a Cleared decision on August 14, 1998 after a review of 52 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 Arc Medical, Inc. devices

FDA 510(k) Submission Details - K982239

510(k) Number K982239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1998
Decision Date August 14, 1998
Days to Decision 52 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 129d · This submission: 52d
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 117
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K982239.
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
LICHEN, BACTERIAL IN LINE BREATHING FILTER
K980662 · Dhd Healthcare Corp. · Sep 1998
POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER
K982127 · Porous Media Corp. · Jun 1998
BREATHING CIRCUIT BACTERIAL FILTER
K973797 · King Systems Corp. · Mar 1998
ZEFON ADULT ANESTHESIA BREATHING CIRCUIT WITH FILTER, ZEFON PEDIATRIC ANESTHESIA BREATHING CIRCUIT WITH FILTER
K973238 · Bill Olson Corp. · Mar 1998