Data / Medical devices / United States / King Systems Corporation.
King Systems Corporation.: FDA-registered device maker in Noblesville, IN, United States, 8 510(k) clearances
King Systems Corporation. is registered with the FDA (registration 1824226) in Noblesville, IN, United States. It lists 11 device types. The FDA files 8 510(k) clearances under its listings, the newest dated April 14, 2004. 15 recall events name it as the recalling firm (2 Class I). Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 1824226
- Address
- 15011 Herriman BLVD., Noblesville, IN, United States, 46060
- Owner or operator
- KING SYSTEMS (1824226)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- September 27, 1983
- Registered through
- 2027
- Brand names listed
- "Original" King Mask, ANESTHESIA BREATHING CIRCUIT KIT, Adult and Pediatric Anesthesia Breathing Circuit, Adult and Pediatric Ultra Flex, Ambu AuraOnce; Ambu AuraStraight; AMBU LARYNGEAL MASK, F Flex, F Flex2, F2 Filter and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 14, 2004 | K033186 | KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205 | CAE | Substantially Equivalent | King Systems Corp. | accessdata.fda.gov |
| March 1, 1999 | K983817 | BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F) | CAH | Substantially Equivalent | King Systems Corp. | accessdata.fda.gov |
| March 12, 1998 | K973797 | BREATHING CIRCUIT BACTERIAL FILTER | CAH | Substantially Equivalent | King Systems Corp. | accessdata.fda.gov |
| November 3, 1995 | K953513 | XENON CIRCUIT | IYT | Substantially Equivalent | King Systems Corp. | accessdata.fda.gov |
| April 29, 1988 | K880681 | MINI-FILTER, VIROBAC II | CAH | Substantially Equivalent | King Systems Corp. | accessdata.fda.gov |
| March 21, 1988 | K880682 | MASK, ANESTH. INFLATABLE & PEDIATRIC SCENTED, DISP | BSJ | Substantially Equivalent | King Systems Corp. | accessdata.fda.gov |
| March 9, 1988 | K880683 | KING SYSTEMS, DISP. ANESTHESIA BREATHING CIRCUIT | CAI | Substantially Equivalent | King Systems Corp. | accessdata.fda.gov |
| March 3, 1988 | K880680 | KING SYSTEMS, BREATHING BAG | BTC | Substantially Equivalent | King Systems Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 26, 2024 | 95451 | Class II | Ongoing | AMBU / KING LTSD, SIZE 0,1 W/SUCTION PORT, STERILE- Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD420 | Exceed the limitations to the 510 (k) exemption in 21 CFR 868.9(a) because it introduces a new indication for pediatric use in an Oropharyngeal Airway. | accessdata.fda.gov |
| November 5, 2019 | 84415 | Class I | Terminated | King Vision Video Adapter Size 1/2. Laryngoscope used to examine and visualize a patients upper airway and aid in the placement of a tracheal tube. Model Number: KVLVA12 | Exhibiting a reversed image. Although the image may appear normal, the users actions will be reversed on the display for left and right directions. | accessdata.fda.gov |
| January 4, 2019 | 82036 | Class II | Terminated | King LTS-D Kit Size 1, Model Number KLTSD431 | Size 0 products were incorrectly packaged and labeled as a size 1 products. | accessdata.fda.gov |
| March 15, 2017 | 78799 | Class II | Terminated | UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390-6121Z, D495-61Z, DF4116-6121Z, D466-61Z, DFP170-6121, DF3115-6121Z, DF375-6121Z, DF3115-6121Z, DF3115-6121Z, D360-8031Z, D465-61Z, JD365-6033Z | Potential for leak test failures. | accessdata.fda.gov |
| February 17, 2015 | 70610 | Class II | Terminated | 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 tu | Product is mislabeled as Double Swivel Connector with Suction Port and is actually Double Swivel Connector without Suction port. If the incorrect component is not identified prior to clinical use, the incorrect connector would be replaced during the case without risk to the patient and could result in a short delay of the procedure. | accessdata.fda.gov |
| September 3, 2013 | 66185 | Class III | Terminated | 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 cons | Report that size 5 KLTD airways were packaged in pouches indicating a size of 2.5 and shipped to your facility. The correct size of the KLTD airway is clearly marked on the actual airway product and the physical size difference between 2.5 and 5 is distinct and obvious. | accessdata.fda.gov |
| November 2, 2012 | 63580 | Class II | Terminated | 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 | The firm received two complaints from a user facility in New Jersey regarding color-coded EtO sterilization indicators on the primary device packaging that did not undergo the expected color change. The complainant reported devices that had pink color indicators when the product packaging specified that the color should change from pink to yellow (or brown) | accessdata.fda.gov |
| August 23, 2012 | 66184 | Class I | Terminated | 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 inhalation and exhalati | King Systems received a customer complaint indicating that the customer had ordered a breathing circuit with a Latex breathing bag. The product they received contained a Latex breathing bag, but was labeled as non-latex. | accessdata.fda.gov |
| January 24, 2011 | 57972 | Not yet classified | Terminated | 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. | The firm is conducting a subrecall of facetent masks because the masks could have a sticky substance on the inside or outside of the mask that may manifest itself 6-8 months after the manufacture date of the product. The sticky substance could result in inconvenience or in some remote cases cause patient harm. | accessdata.fda.gov |
| January 24, 2011 | 57810 | Not yet classified | Terminated | 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 is a device inserted th | The firms contract manufacturer reported that the products were below the specification for hardness. This could contribute to a higher incidence of problems during the insertion and final positioning of the airway in the patient. In rare instances the softness of the tube could cause the tube to fold over. | accessdata.fda.gov |
| January 14, 2011 | 57970 | Not yet classified | Terminated | 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 Boulevard, Noblesville, IN 46 | King Systems has been notified by Triad Group, our supplier of sterile lubricating jelly, that a recall has been initiated for this product because the product may be "inadequately sterilized" and use of this product may result in "patient infection". Because this particular sterile lubricating jelly is packaged in the KING LT-D Kit and KING LTS-D Kit, King | accessdata.fda.gov |
| December 15, 2009 | 54350 | Not yet classified | Terminated | KING LT -D Size 3, 10-0002, Oropharyngeal Airway. King Systems Corporation 15011 Herriman Boulevard, Noblesville, IN 46060. Airway management by providing a patent airway to allow patient ventilation. | King Systems was issued a warning letter from the Center for Devices and Radiological Health, Office of Compliance on October 28, 2009. The warning letter asserts that Kings Systems KLT(S)-D airway exceeds cleared indications in that it is promoted for "airway management in patients over 4 feet in height, for controlled or spontaneous ventilation, difficult | accessdata.fda.gov |
| August 1, 2008 | 48991 | Not yet classified | Terminated | King Systems, Datex-Ohmeda, Universal Flex2 Breathing Circuit, Latex Free, 50 per case, King Systems Corporation, Noblesville, IN; REF # CP-05204. This breathing circuit is a device intended to administer medical gases a | The inner line may be severed or broken into two pieces, thus hindering the delivery of oxygen and anesthetics to the patient and possibly elevated patient carbon dioxide levels. | accessdata.fda.gov |
| December 13, 13 | 66869 | Class II | Terminated | 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 | KLTD214 airways found inside KLTSD414 packages. The KLTSD414 airway has a lumen for use of a gastric suction tube; the KLTD214 airway does not include a lumen for a gastric suction tube. | accessdata.fda.gov |
| December 13, 12 | 66189 | Class II | Terminated | 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 th | On December 13, 2012, King Systems initiated a voluntary recall of one (1) case(s) (5) individual products) from one (1) lot [(IV1V3) 62 cases, 310 products]of King LTSD Oropharyngeal Airways because the package label indicated that the airway was a size 5 when in fact the airway in the package was a size 4. When King manufacturers a lot, all of the componen | accessdata.fda.gov |
Compare with other makers
- All makers of Connector, Airway (Extension)
- All makers of Airway, Oropharyngeal, Anesthesiology
- All makers of Anesthesia Breathing Circuit Kit (Adult & Pediatric)
- All makers of Circuit, Breathing (W Connector, Adaptor, Y Piece)
- All makers of Filter, Bacterial, Breathing-Circuit
- All makers of System, Rebreathing, Radionuclide
Updated October 30, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.