# K904172: Accuplace (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Dlp, Inc.
- Decided: Nov 21, 1990 after 71 days
- Product code: GDF (Guide, Needle, Surgical)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: 4 (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
- Feb 4, 2016 · Class II · Z-1037-2016: During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.
- Feb 4, 2016 · Class II · Z-1038-2016: During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.
- Feb 4, 2016 · Class II · Z-1039-2016: During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.
- Feb 4, 2016 · Class II · Z-1040-2016: During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.

Source page: https://510kreport.com/device/K904172
Methodology: https://510kreport.com/methodology