King Systems Corp.
King Systems Corp. holds FDA 510(k) medical device clearances, first cleared 1988, most recent 2004, with 15 FDA device recalls on record.
Top product codes for King Systems Corp.
FDA recalls by King Systems Corp.
10 most recent of 15- Z-1361-2015 — Double Swivel Connector with Suction Port Connector, Airway (Extension) King Systems part 7169 Product Usage: An airway connector is a device intended to connect a breathing gas source to a tracheal tube, tracheostomy tube, or gas mask. The double swivel connector with suction port is an optional connector for a breathing circuit. King System s offers two versions of the double swivel connector, one with a suction port and one without a suction port. The clinical significance of the suction port is that it provides the caregiver the opportunity to perform a secondary procedure if so desired.
- Z-0709-2014 — King Systems KLTSD414 Quantity, 5 PER CASE KING LTSD KIT SIZE 4 King LT(S)-DTM supraglottic airway Identification Part Number(s): KLTSD414 KING LTSD KIT/KIT/TROUSSE/KIT SIZE 4 Contents: 1 - KLTSD Size 4......(155 - 180cm) .. 1 - 60cc Syringe 1 - Sterile Lubricant 32-5332 05/10 Intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration.
- Z-0002-2014 — King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
- Z-2255-2013 — King LT-D Oropharyngeal Airways The King LT-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
- Z-0425-2013 — KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 20 devices/case Size 2 / Infant ClearSeal Flexible King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
- Z-0419-2013 — KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 3 / Child Silicone King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway
- Z-0427-2013 — KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case "Size 4 / Adult ClearSeal Flexible King LAD¿ Patient Size: 50-70kg " Product Usage: Laryngeal airway
- Z-0422-2013 — KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie10 devices/case Size 3 / Child ClearSeal King LAD¿ Patient Size: 30-50kg Product Usage: Laryngeal airway
- Z-0421-2013 — KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway
- Z-0418-2013 — KING LAD SILI CONE SINGLE USE, King Systems devices/case, ETO Sterile. Size 2 / Infant Silicone King LAD¿ Patient Size: 10-20kg Product Usage: Laryngeal airway
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by King Systems Corp.
- K033189 — KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305
- K033186 — KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205
- K021634 — KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105
- K012485 — MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE
- K010040 — SLEEVED FILTER
- K990614 — HME-BOOSTER
- K983817 — BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F)
- K973797 — BREATHING CIRCUIT BACTERIAL FILTER
- K953513 — XENON CIRCUIT
- K951093 — KAB SYSTEM
- K950318 — FLEX BLUE
- K943402 — K.P.R. (KING PERSONAL RESUSCITATOR)
- K934441 — KING SYSTEMS HME
- K922789 — KING SYSTEMS CORP. UNIVERSAL F BREATHING CIRCUIT
- K880681 — MINI-FILTER, VIROBAC II
- K880682 — MASK, ANESTH. INFLATABLE & PEDIATRIC SCENTED, DISP
- K880683 — KING SYSTEMS, DISP. ANESTHESIA BREATHING CIRCUIT
- K880680 — KING SYSTEMS, BREATHING BAG
Data sourced from openFDA. This site is unofficial and independent of the FDA.