ClearanceBrief
Panels › Anesthesiology › Product code CAE · Class 1

Airway, Oropharyngeal, Anesthesiology

Regulation 868.5110

0510(k)s in 12 months (57 all time)
3recalls in 12 months (76 all time)
30recalls that name a 510(k)
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Top companies in CAE

DateFirm and productCodeLinked 510(k)
Aug 14, 2026Intersurgical Inc
One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device.
Open, Classified
CAENone listed
Aug 14, 2026Intersurgical Inc
One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device.
Open, Classified
CAENone listed
Jul 31, 2026INTEGRATED MEDCRAFT LLC
FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050.
Open, Classified
CAENone listed
Aug 6, 2025Intersurgical Inc
One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090.
Open, Classified
CAENone listed
Aug 6, 2025Intersurgical Inc
One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080.
Open, Classified
CAENone listed
Oct 30, 2024King Systems Corp. dba Ambu, Inc.
KING LTSD,SIZE 2.5, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KKLTSD4325
Open, Classified
CAENone listed
Oct 30, 2024King Systems Corp. dba Ambu, Inc.
KING LTSD,SIZE 2, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD432
Open, Classified
CAENone listed
Oct 30, 2024King Systems Corp. dba Ambu, Inc.
KING LTSD,SIZE 1, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD431
Open, Classified
CAENone listed
Oct 30, 2024King Systems Corp. dba Ambu, Inc.
KING LTSD,SIZE 0, W/SUCTION PORT NON-STERILE KIT-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD430
Open, Classified
CAENone listed
Oct 30, 2024King Systems Corp. dba Ambu, Inc.
KING LTSD,SIZE 2.5, W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD4225
Open, Classified
CAENone listed
Oct 30, 2024King Systems Corp. dba Ambu, Inc.
KING LTSD,SIZE 2,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD422
Open, Classified
CAENone listed
Oct 30, 2024King Systems Corp. dba Ambu, Inc.
KING LTSD,SIZE 1,W/SUCTION PORT STERILE-Inserted into a patient s pharynx through the mouth to provide patent airway. Model/Catalog Number: KLTSD421
Open, Classified
CAENone listed
Oct 30, 2024King Systems Corp. dba Ambu, Inc.
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
Open, Classified
CAENone listed
Sep 6, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits, labeled as: 1) TRACH CDS-LF , Pack Number CDS983142B ; 2) MER TRACH CDS , Pack Number CDS984376B ; 3) Flexible LMA Pack with Syringe and Lube, Size 1, Pack Number DYND30
Open, Classified
CAENone listed
Feb 25, 2024MEDLINE INDUSTRIES, LP - Northfield
MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511
Open, Classified
CAENone listed
Jan 12, 2024Sarnova HC, Llc
Curaplex Cricothyrotomy Field Kit with Instruments, Kwik Cric MVP, 6.0mm, Item Number 351631i-A. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.
Open, Classified
CAENone listed
Jan 12, 2024Sarnova HC, Llc
Curaplex Field Cric Kit with ET Tube, Item Number 36611. The kit provides healthcare professionals with an assortment of supplies to perform a cricothyrotomy.
Open, Classified
CAENone listed
Jul 21, 2023MEDLINE INDUSTRIES, LP - Northfield
DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs
Open, Classified
CAENone listed
Jan 26, 2023SunMed Holdings, LLC
AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5 60055 1.0 60105 1.5 60155 2.0 60205 3.0
Open, Classified
CAENone listed
Jan 26, 2023SunMed Holdings, LLC
Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 50105 1.5 50155 2.0 50205 3.0
Open, Classified
CAENone listed
Oct 17, 2022Intersurgical Inc
Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg Model Number: 8003000
Terminated
CAENone listed
Mar 9, 2022MEDLINE INDUSTRIES, LP - Northfield
Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box
Terminated
CAENone listed
May 14, 2020Bound Tree Medical
Curaplex Ambu King LTS-D Supraglottic Airway Kit with ET Tube Part Number: KLTSD404K Curaplex Ambu King LTS-D" Supraglottic Airway Kit with ET Tube (hereafter the Kit which contains all of the comp
Terminated
CAENone listed
Jan 4, 2019King Systems Corp. dba Ambu, Inc.
King LTS-D Kit Size 1, Model Number KLTSD431
Terminated
CAENone listed
Aug 9, 2018Besmed Health Business Corporation
Ambu Aura40 Standard, Reusable Laryngeal Mask Catalog Number: 340300000
Terminated
CAENone listed
Jun 29, 2016Carefusion 2200 Inc
Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored Pouches, Product Code 7730MOD
Terminated
CAENone listed
Jun 29, 2016Carefusion 2200 Inc
Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2
Terminated
CAENone listed
Feb 10, 2015Teleflex Medical
LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, Product Usage: Achieve and maintain control of airway during routine anaesthesia in fasted patient using either spontaneo
Terminated
CAENone listed
Jan 10, 2014King 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
CAENone listed
Oct 1, 2013King 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
CAENone listed
Sep 19, 2013King 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
CAENone listed
Nov 21, 2012King 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
CAENone listed
Nov 21, 2012King 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
CAENone listed
Nov 21, 2012King 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
CAENone listed
Nov 21, 2012King 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
CAENone listed
Nov 21, 2012King 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
CAENone listed
Nov 21, 2012King 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
CAENone listed
Nov 21, 2012King 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
CAENone listed
Nov 21, 2012King 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
CAENone listed
Nov 21, 2012King 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
CAENone listed
Nov 21, 2012King 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
CAENone listed
Apr 4, 2011King 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
CAENone listed
Apr 4, 2011King 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
CAENone listed
Mar 17, 2011King 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
CAEK021634
K033186
Mar 17, 2011King 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
CAEK021634
K033186
Mar 17, 2011King 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
CAEK021634
K033186
Mar 17, 2011King 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
CAEK021634
K033186
Mar 17, 2011King 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
CAEK021634
K033186
Mar 17, 2011King 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
CAEK021634
K033186
Mar 17, 2011King 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
CAEK021634
K033186

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