# K954015: Abg Point Lok Needle Protection Device

- Pathway: 510(k) (Traditional)
- Applicant: Devon Industries, Inc.
- Decided: Nov 20, 1995 after 87 days
- Product code: CBT (Arterial Blood Sampling Kit)
- Device class: 1
- Regulation: 21 CFR 868.1100
- Recalls of this device: 3 (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
- Mar 29, 2004 · Not classified · Z-0858-04: Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after steri
- Mar 29, 2004 · Not classified · Z-0860-04: Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after steri
- Mar 29, 2004 · Not classified · Z-0859-04: Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after steri

Source page: https://510kreport.com/device/K954015
Methodology: https://510kreport.com/methodology