Company ยท US
King Systems Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 2004. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
195recalls (0 in 12 months)
30recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 145 |
| CAE | Airway, Oropharyngeal, Anesthesiology | 48 |
| BYG | Mask, Oxygen | 6 |
| CAH | Filter, Bacterial, Breathing-Circuit | 5 |
| BSF | Absorber, Carbon-Dioxide | 1 |
| BSJ | Mask, Gas, Anesthetic | 1 |
| BTC | Bag, Reservoir | 1 |
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | 1 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 1 |
| BZA | Connector, Airway (Extension) | 1 |
| CBH | Device, Fixation, Tracheal Tube | 1 |
| CBP | Valve, Non-Rebreathing | 1 |
| IYT | System, Rebreathing, Radionuclide | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 4, 2004 | K033189 | KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305 King Systems Corp. | CAE |
| Apr 14, 2004 | K033186 | KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205 King Systems Corp. | CAE |
| Jan 9, 2003 | K021634 | KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105 King Systems Corp. | CAE |
| Oct 9, 2001 | K012485 | MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE King Systems Corp. | CAH |
| Mar 9, 2001 | K010040 | SLEEVED FILTER King Systems Corp. | CAH |
| May 23, 2000 | K990614 | HME-BOOSTER King Systems Corp. | BTT |
| Mar 1, 1999 | K983817 | BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F) King Systems Corp. | CAH |
| Mar 12, 1998 | K973797 | BREATHING CIRCUIT BACTERIAL FILTER King Systems Corp. | CAH |
| Nov 3, 1995 | K953513 | XENON CIRCUIT King Systems Corp. | IYT |
| Mar 24, 1995 | K951093 | KAB SYSTEM King Systems Corp. | BSF |
| Feb 13, 1995 | K950318 | FLEX BLUE King Systems Corp. | CBH |
| Aug 19, 1994 | K943402 | K.P.R. (KING PERSONAL RESUSCITATOR) King Systems Corp. | CBP |
| Dec 2, 1993 | K934441 | KING SYSTEMS HME King Systems Corp. | BYD |
| May 26, 1993 | K922789 | KING SYSTEMS CORP. UNIVERSAL F BREATHING CIRCUIT King Systems Corp. | CAI |
| Apr 29, 1988 | K880681 | MINI-FILTER, VIROBAC II King Systems Corp. | CAH |
| Mar 21, 1988 | K880682 | MASK, ANESTH. INFLATABLE & PEDIATRIC SCENTED, DISP King Systems Corp. | BSJ |
| Mar 9, 1988 | K880683 | KING SYSTEMS, DISP. ANESTHESIA BREATHING CIRCUIT King Systems Corp. | CAI |
| Mar 3, 1988 | K880680 | KING SYSTEMS, BREATHING BAG King Systems Corp. | BTC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2015 | King Systems Corp. 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 Terminated |
BZA | None listed |
| Jan 10, 2014 | King Systems Corp. 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 - KL Terminated |
CAE | None listed |
| Oct 1, 2013 | King Systems Corp. 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 Terminated |
CAE | None listed |
| Sep 27, 2013 | King Systems Corp. Universal Flex2 Breathing Circuit
Class I
510(k) Exempt
An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an i Terminated |
CAI | None listed |
| Sep 19, 2013 | King Systems Corp. 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 whe Terminated |
CAE | None listed |
| Nov 21, 2012 | King Systems Corp. 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 Terminated |
CAE | None listed |
| Nov 21, 2012 | King Systems Corp. KING LAD Flexible ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case
"Size 3 / Child ClearSeal Flexible King LAD Patient Size: 30-50kg "
Product Usage:
Laryngeal airway Terminated |
CAE | None listed |
| Nov 21, 2012 | King Systems Corp. 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 Terminated |
CAE | None listed |
| Nov 21, 2012 | King Systems Corp. KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case
Size 5 / Adult ClearSeal King LAD Patient Size: >70kg
Product Usage:
Laryngeal airway Terminated |
CAE | None listed |
| Nov 21, 2012 | King Systems Corp. KING LAD Standard ClearSeal SINGLE USE, King Systems ETO Sterilie, 10 devices/case
Size 4 / Adult ClearSeal King LAD Patient Size: 50-70kg
Product Usage:
Laryngeal airway Terminated |
CAE | None listed |
| Nov 21, 2012 | King Systems Corp. 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 Terminated |
CAE | None listed |
| Nov 21, 2012 | King Systems Corp. 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 Terminated |
CAE | None listed |
| Nov 21, 2012 | King Systems Corp. KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile
Size 4 / Adult Silicone King LAD Patient Size: 50-70kg Terminated |
CAE | None listed |
| Nov 21, 2012 | King Systems Corp. 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 Terminated |
CAE | None listed |
| Nov 21, 2012 | King Systems Corp. 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 Terminated |
CAE | None listed |
| Apr 6, 2011 | King Systems Corp. Universal F Anesthesia Breathing Circuit, REF 5U345-611XB, Manufacturer: King Systems, Nobleville, IN.
An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administ Terminated |
BYG | None listed |
| Apr 6, 2011 | King Systems Corp. Universal F2 Anesthesia Breathing Circuit, REF 5D440-61X-17, Manufacturer: King Systems, Nobleville, IN.
An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to admini Terminated |
BYG | None listed |
| Apr 6, 2011 | King Systems Corp. Aerosol mask with 15 mm adapter, REF S-MD127, Manufacturer: King Systems, Nobleville, IN.
An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or Terminated |
BYG | None listed |
| Apr 6, 2011 | King Systems Corp. Aerosol Mask with 15 mm Adapter, REF MD127, Manufacturer: King Systems, Nobleville, IN.
An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or ae Terminated |
BYG | None listed |
| Apr 6, 2011 | King Systems Corp. Face Tent with 15 mm Adapter, REF S-MD126, Manufacturer: King Systems Nobleville, IN.
An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aeroso Terminated |
BYG | None listed |
| Apr 6, 2011 | King Systems Corp. Face Tent with 15 mm Adapter, REF MD126, Manufacturer: King Systems Nobleville, IN.
An oxygen mask is a device placed over a patient's nose, mouth, or tracheostomy to administer oxygen or aerosols Terminated |
BYG | None listed |
| Apr 4, 2011 | King Systems Corp. King System , King LTS-D Kit Size 5, Sterile, REF KLTSD405, Manufacturer: King Systems Noblesville, IN.
Ventilation during anesthesia during procedures of short duration. An oropharyngeal airway is a Terminated |
CAE | None listed |
| Apr 4, 2011 | King Systems Corp. King System , King LTSD Kit Size 4, non-sterile, REF KLTSD414, Manufacturer: King Systems Noblesville, IN.
Ventilation during anesthesia during procedures of short duration. An oropharyngeal airway i Terminated |
CAE | None listed |
| Mar 17, 2011 | King Systems Corp. KING SYSTEMS, A Consort Medical Company, KLTSD415, Quantity: 5 PER CASE, KING KLTSD, KIT SIZE 5, Manufacturer: King Systems Corporation, 15011 Herriman Boulevard, Noblesville, IN 46060, 317-776-6823, Terminated |
CAE | K021634 K033186 |
| Mar 17, 2011 | King Systems Corp. KING SYSTEMS, A Consort Medical Company, KLTSD414, Quantity: 5 PER CASE, KING LTSD, KIT SIZE 4, Manufacturer: King Systems Corporation, 15011 Herriman Boulevard, Noblesville, IN 46060, 317-776-6823, M Terminated |
CAE | K021634 K033186 |
| Mar 17, 2011 | King Systems Corp. KING SYSTEMS, A Consort Medical Company, KLTSD413, Quantity: 5 PER CASE, KING LTSD, KIT SIZE 3, Manufacturer: King Systems Corporation, 15011 Herriman Boulevard, Noblesville, IN 46060, 317-776-6823, M Terminated |
CAE | K021634 K033186 |
| Mar 17, 2011 | King Systems Corp. KING SYSTEMS, A Consort Medical Company, KLTD215, Quantity: 5 PER CASE, KING LT-D, KIT SIZE 5, Manufacturer: King Systems Corporation, 15011 Herriman Boulevard, Noblesville, IN 46060, 317-776-6823, Ma Terminated |
CAE | K021634 K033186 |
| Mar 17, 2011 | King Systems Corp. KING SYSTEMS, A Consort Medical Company, KLTD214, Quantity: 5 PER CASE, KING LT-D, KIT SIZE 4, Manufacturer: King Systems Corporation, 15011 Herriman Boulevard, Noblesville, IN 46060, 317-776-6823, Ma Terminated |
CAE | K021634 K033186 |
| Mar 17, 2011 | King Systems Corp. KING SYSTEMS, A Consort Medical Company, KLTD213, Quantity: 5 PER CASE, KING LT-D, KIT SIZE 3, Manufacturer: King Systems Corporation, 15011 Herriman Boulevard, Noblesville, IN 46060, 317-776-6823, Ma Terminated |
CAE | K021634 K033186 |
| Mar 17, 2011 | King Systems Corp. KING SYSTEMS, A Consort Medical Company, KLTD2125, Quantity: 5 PER CASE, KING LT-D, KIT SIZE 2.5, ManufactureR: King Systems Corporation, 15011 Herriman Boulevard, Noblesville, IN 46060, 317-776-6823, Terminated |
CAE | K021634 K033186 |
| Mar 17, 2011 | King Systems Corp. KING SYSTEMS, A Consort Medical Company, KLTD212, Quantity: 5 PER CASE, KING LT-D, KIT SIZE 2, Manufacturer: King Systems Corporation, 15011 Herriman Boulevard, Noblesville, IN 46060, 317-776-6823, Ma Terminated |
CAE | K021634 K033186 |
| Mar 17, 2011 | King Systems Corp. CRQ425, Cardiac ResQ Kit, Quantity 3 units, KING SYSTEMS, A Consort Medical Company, Noblesville, IN 46060, www.kingsystems.com, 317-776-6823.
Advanced Circulatory Systems, Inc., Eden Prairie, MN, ww Terminated |
CAE | K021634 K033186 |
| Mar 17, 2011 | King Systems Corp. CRQ424, Cardiac ResQ Kit, Quantity 3 units, KING SYSTEMS, A Consort Medical Company, Noblesville, IN 46060, www.kingsystems.com, 317-776-6823.
Advanced Circulatory Systems, Inc., Eden Prairie, MN, ww Terminated |
CAE | K021634 K033186 |
| Mar 17, 2011 | King Systems Corp. CRQ423, Cardiac ResQ Kit, Quantity 3 units, KING SYSTEMS, A Consort Medical Company, Noblesville, IN 46060, www.kingsystems.com, 317-776-6823.
Advanced Circulatory Systems, Inc., Eden Prairie, MN, ww Terminated |
CAE | K021634 K033186 |
| Mar 17, 2011 | King Systems Corp. KING LTS-D, SIZE 5, QUANTITY 5 EACH,
Distributed by North American Rescue, Greer, South Carolina, 26950-4791, Products with a Mission, Manufactured by King Systems Corporation, 15011 Herriman Bouleva Terminated |
CAE | K021634 K033186 |
| Mar 17, 2011 | King Systems Corp. KING LTS-D, SIZE 4, QUANTITY 5 EACH,
Distributed by North American Rescue, Greer, South Carolina, 26950-4791, Products with a Mission, Manufactured by King Systems Corporation, 15011 Herriman Bouleva Terminated |
CAE | K021634 K033186 |
| Mar 17, 2011 | King Systems Corp. KING LTS-D, SIZE 3, QUANTITY 5 EACH,
Distributed by North American Rescue, Greer, South Carolina, 26950-4791, Products with a Mission, Manufactured by King Systems Corporation, 15011 Herriman Bouleva Terminated |
CAE | K021634 K033186 |
| Mar 17, 2011 | King Systems Corp. KING LTD, SIZE 5, QUANTITY 1 EACH,
Distributed by North American Rescue, Greer, South Carolina, 26950-4791, Products with a Mission, Manufactured by King Systems Corporation, 15011 Herriman Boulevard Terminated |
CAE | K021634 K033186 |
| Mar 17, 2011 | King Systems Corp. KING LTD, SIZE 4, QUANTITY 1 EACH,
Distributed by North American Rescue, Greer, South Carolina, 26950-4791, Products with a Mission, Manufactured by King Systems Corporation, 15011 Herriman Boulevard Terminated |
CAE | K021634 K033186 |
| Mar 17, 2011 | King Systems Corp. KING LT-D, SIZE 3, QUANTITY 1 EACH,
Distributed by North American Rescue, Greer, South Carolina, 26950-4791, Products with a Mission, Manufactured by King Systems Corporation, 15011 Herriman Boulevar Terminated |
CAE | K021634 K033186 |
| Jan 27, 2011 | King Systems Corp. KING LT -D Laryngeal Tube, Size 4, KLTD204, King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060.
Intended use: Airway management by providing a patent airway to allow patient ve Terminated |
CAE | K021634 K033186 |
| Jan 27, 2011 | King Systems Corp. KING LT -D Lanyngeal Tube, Size 3, KLTD203, King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060.
Intended use: Airway management by providing a patent airway to allow patient ve Terminated |
CAE | K021634 K033186 |
| Jan 27, 2011 | King Systems Corp. KING LT -D Laryngeal Tube, Size 2.5 KLTD2025, King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060.
Intended use: Airway management by providing a patent airway to allow patient Terminated |
CAE | K021634 K033186 |
| Jan 27, 2011 | King Systems Corp. KING LT -D Laryngeal Tube, Size 2, KLTD202, King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060.
Intended use: Airway management by providing a patent airway to allow patient v Terminated |
CAE | K021634 K033186 |
| Jan 27, 2011 | King Systems Corp. Cardiac ResQ Kit, Size 5, CRQ425, King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060.
Intended use: Airway management by providing a patent airway to allow patient ventilation Terminated |
CAE | K021634 K033186 |
| Jan 27, 2011 | King Systems Corp. Cardiac ResQ Kit, Size 4, CRQ424, King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060.
Intended use: Airway management by providing a patent airway to allow patient ventilation Terminated |
CAE | K021634 K033186 |
| Jan 27, 2011 | King Systems Corp. Cardiac ResQ Kit , Size 3, CRQ423, Oropharyngeal Airway. King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060.
Intended use: Airway management by providing a patent airway to all Terminated |
CAE | K021634 K033186 |
| Jan 27, 2011 | King Systems Corp. KING LTS -D, Size 5, 10-0027, Oropharyngeal Airway. King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060.
Intended use: Airway management by providing a patent airway to allow p Terminated |
CAE | K021634 K033186 |
| Jan 27, 2011 | King Systems Corp. KING LTS -D, Size 4, 10-0026, Oropharyngeal Airway. King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060.
Intended use: Airway management by providing a patent airway to allow p Terminated |
CAE | K021634 K033186 |
| Jan 27, 2011 | King Systems Corp. KING LTS -D, Size 3, 10-0025, Oropharyngeal Airway. King Systems Corporation, 15011 Herriman Boulevard, Noblesville, IN 46060.
Intended use: Airway management by providing a patent airway to allo Terminated |
CAE | K021634 K033186 |
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