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)
Top companies in CAE
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2026 | Intersurgical Inc One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway Device. Open, Classified |
CAE | None listed |
| Aug 14, 2026 | Intersurgical Inc One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device. Open, Classified |
CAE | None listed |
| Jul 31, 2026 | INTEGRATED 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 |
CAE | None listed |
| Aug 6, 2025 | Intersurgical Inc One-piece Guedel airway, size 3, ISO 9.0, yellow. Model Number: 1113090. Open, Classified |
CAE | None listed |
| Aug 6, 2025 | Intersurgical Inc One-piece Guedel airway, size 2, ISO 8.0, green. Model Number: 1112080. Open, Classified |
CAE | None listed |
| Oct 30, 2024 | King 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 |
CAE | None listed |
| Oct 30, 2024 | King 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 |
CAE | None listed |
| Oct 30, 2024 | King 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 |
CAE | None listed |
| Oct 30, 2024 | King 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 |
CAE | None listed |
| Oct 30, 2024 | King 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 |
CAE | None listed |
| Oct 30, 2024 | King 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 |
CAE | None listed |
| Oct 30, 2024 | King 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 |
CAE | None listed |
| Oct 30, 2024 | King 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 |
CAE | None listed |
| Sep 6, 2024 | MEDLINE 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 |
CAE | None listed |
| Feb 25, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE TRAY TRACH BASIC SOLUTION, REF DYND40511 Open, Classified |
CAE | None listed |
| Jan 12, 2024 | Sarnova 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 |
CAE | None listed |
| Jan 12, 2024 | Sarnova 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 |
CAE | None listed |
| Jul 21, 2023 | MEDLINE INDUSTRIES, LP - Northfield DYND3000xxP Series - Flexible Laryngeal Mask Airway Packs Open, Classified |
CAE | None listed |
| Jan 26, 2023 | SunMed 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 |
CAE | None listed |
| Jan 26, 2023 | SunMed 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 |
CAE | None listed |
| Oct 17, 2022 | Intersurgical Inc Intersurgical Solus Standard, laryngeal mask airway, size 3, small adult, 30-50kg
Model Number: 8003000 Terminated |
CAE | None listed |
| Mar 9, 2022 | MEDLINE INDUSTRIES, LP - Northfield Medline Standard PVC Laryngeal Masks, 1 device per pouch, 5 each pouches per box Terminated |
CAE | None listed |
| May 14, 2020 | Bound 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 |
CAE | None listed |
| Jan 4, 2019 | King Systems Corp. dba Ambu, Inc. King LTS-D Kit Size 1, Model Number KLTSD431 Terminated |
CAE | None listed |
| Aug 9, 2018 | Besmed Health Business Corporation Ambu Aura40 Standard, Reusable Laryngeal Mask
Catalog Number: 340300000 Terminated |
CAE | None listed |
| Jun 29, 2016 | Carefusion 2200 Inc Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, Broselow Complete Set of Colored Pouches, Product Code 7730MOD Terminated |
CAE | None listed |
| Jun 29, 2016 | Carefusion 2200 Inc Broselow/Hinkle, PEDIATRIC EMERGENCY SYSTEM, PINK/RED Oxygen Delivery Module 2/PACK, Product Code 7700RAW2 Terminated |
CAE | None listed |
| Feb 10, 2015 | Teleflex 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 |
CAE | 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 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 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 |
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