Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

King Systems Corp. — Predicate Candidate Screening

18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

83 daysmedian FDA review time
351 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K033189KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHKing Systems Corp.2004-05-042160
K033186KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KKing Systems Corp.2004-04-1419630
K021634KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 10King Systems Corp.2003-01-0923730
K012485MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUKing Systems Corp.2001-10-09680
K010040SLEEVED FILTERKing Systems Corp.2001-03-09630
K990614HME-BOOSTERKing Systems Corp.2000-05-234530
K983817BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGKing Systems Corp.1999-03-011230
K973797BREATHING CIRCUIT BACTERIAL FILTERKing Systems Corp.1998-03-121570
K953513XENON CIRCUITKing Systems Corp.1995-11-031000
K951093KAB SYSTEMKing Systems Corp.1995-03-24150
K950318FLEX BLUEKing Systems Corp.1995-02-13180
K943402K.P.R. (KING PERSONAL RESUSCITATOR)King Systems Corp.1994-08-19360
K934441KING SYSTEMS HMEKing Systems Corp.1993-12-02830
K922789KING SYSTEMS CORP. UNIVERSAL F BREATHING CIRCUITKing Systems Corp.1993-05-263510
K880681MINI-FILTER, VIROBAC IIKing Systems Corp.1988-04-29700
K880682MASK, ANESTH. INFLATABLE & PEDIATRIC SCENTED, DISPKing Systems Corp.1988-03-21310
K880683KING SYSTEMS, DISP. ANESTHESIA BREATHING CIRCUITKing Systems Corp.1988-03-09190
K880680KING SYSTEMS, BREATHING BAGKing Systems Corp.1988-03-03130

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda