KING SYSTEMS CORPORATION.

Activity by year

Devices registered here (1)

• Airway, Oropharyngeal, Anesthesiology
  Product code CAE (opens in a new tab) · Class I · Anesthesiology · 21 CFR 868.5110

Recalls & enforcement

• Class IIOngoing2024-09-26
  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.
• Class ITerminated2019-11-05
  Exhibiting a reversed image. Although the image may appear normal, the users actions will be reversed on the display for left and right directions.
• Class IITerminated2019-01-04
  Size 0 products were incorrectly packaged and labeled as a size 1 products.
• Class IITerminated2017-03-15
  Potential for leak test failures.
• Class IITerminated2015-02-17
  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 patie…
• Class IITerminated2013-12-13
  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.
• Class IITerminated2013-12-12
  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…
• Class IIITerminated2013-09-03
  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.
• Class IITerminated2012-11-02
  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…
• Class ITerminated2012-08-23
  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.

FDA inspections (3)

• OAI2023-05-16
  Official Action Indicated · Compliance: Devices
• VAI2021-04-15
  Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted
• VAI2017-11-28
  Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

• Warning Letter2023-08-16
  Warning Letter (opens in a new tab) · Noblesville Indiana

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

Related

• All facilities operated by KING SYSTEMS

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)