# K801393: Air Aspirator Needle

- Pathway: 510(k) (Traditional)
- Applicant: Texas Medical Products, Inc.
- Decided: Jun 30, 1980 after 17 days
- Product code: DWS (Instruments, Surgical, Cardiovascular)
- Device class: 1
- Regulation: 21 CFR 870.4500
- Recalls of this device: 1 (0 Class I)
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Nov 24, 2003 · Not classified · Z-0281-04: The firm packaged Modified Air Aspirator Needles into Pediatric Air Aspirator Needle boxes.

Source page: https://510kreport.com/device/K801393
Methodology: https://510kreport.com/methodology