# K191602: APA Oxy Blade

- Pathway: 510(k) (Traditional)
- Applicant: Venner Medical (Singapore) Pte, Ltd.
- Decided: Aug 2, 2019 after 46 days
- Product code: CCW (Laryngoscope, Rigid)
- Device class: 1
- Regulation: 21 CFR 868.5540
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Venner Medical APA MAC Blade: named in the summary without a submission number
- (no number) Vyaire Medical Airlife Oxygen Supply Tubing: named in the summary without a submission number

## Indications for use
The APA Oxy Blade™ is a multi-functional, single-use, disposable larynoscope blade intended to assist in direct and indirect laryngoscopy and to facilitate and aid in tracheal intubation in routine and difficult airways in adult patients. The APA Oxy Blade™ incorporates an oxygen tube adaptor and tubing to provide supplemental oxygen to the patient while undergoing endotracheal intubation.

Source page: https://510kreport.com/device/K191602
Methodology: https://510kreport.com/methodology