Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Select Medical Systems, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
83 daysmedian FDA review time
393 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K012935 | THECURVE, ITEM 507 | Select Medical Systems, Inc. | 2001-10-11 | 41 | 0 |
| K974819 | SELECTCELLS(TM) MINI | Select Medical Systems, Inc. | 1998-03-23 | 90 | 0 |
| K954099 | SELECT IUI | Select Medical Systems, Inc. | 1995-11-22 | 83 | 0 |
| K954097 | SELECTCELLS STANDARD | Select Medical Systems, Inc. | 1995-11-21 | 82 | 0 |
| K954102 | SELECTMUCUS | Select Medical Systems, Inc. | 1995-11-21 | 82 | 0 |
| K942922 | SELECTA 20/60 CHEMISTRY ANALYZER | Select Medical Systems, Inc. | 1995-07-19 | 393 | 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