King Systems Corp.
FDA Regulatory Profile
King Systems Corp. appears in FDA public data with 15 recalls — including 1 Class I (most serious) —, 18 510(k) clearances, 8 FDA inspections, and 3 compliance actions on record. Its most recent recall (Z-1361-2015, Class II) was initiated on February 17, 2015. Its most recent 510(k) clearance was granted on May 4, 2004.
Summary
- Total Recalls
- 15 (1 Class I)
- 510(k) Clearances
- 18
- Inspections
- 8
- Compliance Actions
- 3
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1361-2015 | Class II | Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part 7169 | February 17, 2015 |
| Z-0709-2014 | Class II | King Systems KLTSD414 Quantity, 5 PER CASE KING LTSD KIT SIZE 4 King LT(S)-DTM supraglotti | December 13, 2013 |
| Z-0002-2014 | Class II | King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult pa | December 12, 2013 |
| Z-2255-2013 | Class III | King LT-D Oropharyngeal Airways The King LT-D is intended for use in adult patients (in excess of | September 3, 2013 |
| Z-0427-2013 | Class II | KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult | November 2, 2012 |
| Z-0418-2013 | Class II | KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone Ki | November 2, 2012 |
| Z-0423-2013 | Class II | KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 4 / Adult C | November 2, 2012 |
| Z-0420-2013 | Class II | KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 4 / Adult Silicone K | November 2, 2012 |
| Z-0426-2013 | Class II | KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 3 / Child | November 2, 2012 |
| Z-0424-2013 | Class II | KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case Size 5 / Adult C | November 2, 2012 |
| Z-0422-2013 | Class II | KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child Cle | November 2, 2012 |
| Z-0421-2013 | Class II | KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone K | November 2, 2012 |
| Z-0425-2013 | Class II | KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant | November 2, 2012 |
| Z-0419-2013 | Class II | KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone K | November 2, 2012 |
| Z-2272-2013 | Class I | Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia breathing circuit is a d | August 23, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K033189 | KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 3 | May 4, 2004 |
| K033186 | KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205 | April 14, 2004 |
| K021634 | KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105 | January 9, 2003 |
| K012485 | MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 A | October 9, 2001 |
| K010040 | SLEEVED FILTER | March 9, 2001 |
| K990614 | HME-BOOSTER | May 23, 2000 |
| K983817 | BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F) | March 1, 1999 |
| K973797 | BREATHING CIRCUIT BACTERIAL FILTER | March 12, 1998 |
| K953513 | XENON CIRCUIT | November 3, 1995 |
| K951093 | KAB SYSTEM | March 24, 1995 |
| K950318 | FLEX BLUE | February 13, 1995 |
| K943402 | K.P.R. (KING PERSONAL RESUSCITATOR) | August 19, 1994 |
| K934441 | KING SYSTEMS HME | December 2, 1993 |
| K922789 | KING SYSTEMS CORP. UNIVERSAL F BREATHING CIRCUIT | May 26, 1993 |
| K880681 | MINI-FILTER, VIROBAC II | April 29, 1988 |
| K880682 | MASK, ANESTH. INFLATABLE & PEDIATRIC SCENTED, DISP | March 21, 1988 |
| K880683 | KING SYSTEMS, DISP. ANESTHESIA BREATHING CIRCUIT | March 9, 1988 |
| K880680 | KING SYSTEMS, BREATHING BAG | March 3, 1988 |