# K896206: Statspin Statsampler

- Pathway: 510(k) (Traditional)
- Applicant: Statspin Technologies
- Decided: Nov 22, 1989 after 27 days
- Product code: JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection)
- Device class: 2
- Regulation: 21 CFR 862.1675
- 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices 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.

## Most influential descendants
- K983517: Safe-T-Fill Capillary Blood Collection System (1998), 0 descendants of its own
- K981973: Safe-T-Fill Capillary Blood Collection System (1998), 0 descendants of its own

## Recalls of this device
- Jun 20, 2008 · Not classified · Z-2234-2008: EDTA inadvertently mixed with lithium heparin solution contained in capillary tubes.

Source page: https://510kreport.com/device/K896206
Methodology: https://510kreport.com/methodology