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O-Two

O-Two Medical Technologies Inc · Model 01AM3006U · UDI-DI 07540195039063

CAE Prescription

510(k) clearances

1,588

Adverse events (39 deaths)

Recalls

228

Facilities

Description

O-Two Guedel Airway is an oropharyngeal airway insert into a patient’s pharynx through the mouth to provide a patent airway. It provides eight sizes: 40MM, 50MM 60MM, 70MM, 80MM, 90MM, 100MM AND 110MM. The bit block is rigid and identified with color coding. The smooth surface and rounded tip can improve patient comfort. O-Two Guedel Airway is manufactured with 100% Polyethylene (PE) which is latex free and for single use only. The size of 01AM3006 is 90 mm.

Recalls

Date	Firm	Reason
2026-07-07	INTEGRATED MEDCRAFT LLC	Devices could potentially contain an occluded or partially occluded Guedel Airway tip.
2026-06-15	Intersurgical Inc	Devices could potentially be occluded or partially occluded.
2026-06-15	Intersurgical Inc	Devices could potentially be occluded or partially occluded.
2025-06-20	Intersurgical Inc	Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and inf
2025-06-20	Intersurgical Inc	Potential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue irritation, inflammation and inf
2024-09-26	King Systems Corp. dba Ambu, Inc.	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.
2024-09-26	King Systems Corp. dba Ambu, Inc.	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.
2024-09-26	King Systems Corp. dba Ambu, Inc.	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.
2024-09-26	King Systems Corp. dba Ambu, Inc.	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.
2024-09-26	King Systems Corp. dba Ambu, Inc.	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.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.