KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105— 510(k) K021634

Clearance details

Applicant

King Systems Corp.

Product code

Code CAE

Device class

Class 1

Regulation

21 CFR 868.5110

Advisory panel

Anesthesiology

Date received

2002-05-17

Decision date

2003-01-09

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Noblesville, IN, US

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• K955721 — CUFFED OROPHARYNGEAL AIRWAY (COPA)1997-03-28
• K960240 — RUSCH OPTOSAFE1996-04-19

• K012485 — MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE2001-10-09
• K010040 — SLEEVED FILTER2001-03-09
• K990614 — HME-BOOSTER2000-05-23
• K983817 — BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F)1999-03-01
• K973797 — BREATHING CIRCUIT BACTERIAL FILTER1998-03-12

Death

4

Total

4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →