Flexifil Series HC431 Full Face Mask, Model HC431A

510(k) K040506

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

6 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK040506	Date5 May 2004Cleared	StatusActive

6 recalls · FDA

5 recalls, same reason
- Terminated Z-0974-2007 FDA Unclassified (pre-2012) initiated 24 Nov 2006
- Terminated Z-0971-2007 FDA Unclassified (pre-2012) initiated 24 Nov 2006
- Terminated Z-0973-2007 FDA Unclassified (pre-2012) initiated 24 Nov 2006
- Terminated Z-0972-2007 FDA Unclassified (pre-2012) initiated 24 Nov 2006
- Terminated Z-0970-2007 FDA Unclassified (pre-2012) initiated 24 Nov 2006
Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. Masks manufactured since April 2006 do not feat
- Terminated Z-0969-2007 FDA Unclassified (pre-2012) initiated 24 Nov 2006
Plastic tabs incorporated into the connector components of these CPAP masks may break off if they are not cleaned in accordance with the Instructions for Use. In the event of a tab breaking off, it may enter the CPAP system air path and there is an extremely remote possibility that the broken tab may then enter the patient's nasal cavity or mouth. Masks manufactured since April 2006 do not featu

1 jurisdiction

United States — FDA 510(k) Active

510(k)