# K813368: Disposable Chiba-Type Needle

- Pathway: 510(k) (Traditional)
- Applicant: Dlp, Inc.
- Decided: Jan 5, 1982 after 36 days
- Product code: GAA (Needle, Aspiration And Injection, Disposable)
- Device class: 1
- Regulation: 21 CFR 878.4800
- 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
- Dec 20, 2010 · Not classified · Z-1063-2011: This lot of product has the wrong expiration date on the carton label. The pouches contained the correct expiration date.

Source page: https://510kreport.com/device/K813368
Methodology: https://510kreport.com/methodology