Cleared Traditional

K980662 - LICHEN, BACTERIAL IN LINE BREATHING FILTER

K980662 is an FDA 510(k) clearance for LICHEN, manufactured by Dhd Healthcare Corp.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K980662 · Dhd Healthcare Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
206d
Days
Class 2
Risk

K980662 is an FDA 510(k) clearance for the LICHEN, BACTERIAL IN LINE BREATHING FILTER. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Dhd Healthcare Corp. (Wampsville, US). The FDA issued a Cleared decision on September 14, 1998 after a review of 206 days - an extended review 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: 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 Dhd Healthcare Corp. devices

FDA 510(k) Submission Details - K980662

510(k) Number K980662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1998
Decision Date September 14, 1998
Days to Decision 206 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 slower than avg
Panel avg: 129d · This submission: 206d
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 160
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K980662.
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
CIRCUIT GUARD
K982239 · Arc Medical, Inc. · Aug 1998
POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER
K982127 · Porous Media Corp. · Jun 1998
BREATHING CIRCUIT BACTERIAL FILTER
K973797 · King Systems Corp. · Mar 1998