# K840500: Sediplast

- Pathway: 510(k) (Traditional)
- Applicant: Precision Technology, Inc.
- Decided: Feb 21, 1984 after 15 days
- Product code: JPH (Test, Erythrocyte Sedimentation Rate)
- Device class: 1
- Regulation: 21 CFR 864.6700
- 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
- Aug 25, 2026 · Class II · Z-0107-2027: During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be forcibly ejected, pote

Source page: https://510kreport.com/device/K840500
Methodology: https://510kreport.com/methodology