Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Statspin Technologies — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K903698 | STATSPIN MICRO-HEMATOCRIT READER FOR 75MM TUBES | Statspin Technologies | 1990-09-17 | 33 | 0 |
| K896206 | STATSPIN STATSAMPLER | Statspin Technologies | 1989-11-22 | 27 | 1 |
| K893613 | STATSPIN MINI-PLASMA | Statspin Technologies | 1989-08-28 | 110 | 0 |
| K884807 | LIPOCLEAR LIPEMIA CLEARING REAGENT | Statspin Technologies | 1989-01-27 | 71 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda