Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
S.L.P. , Ltd. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
203 daysmedian FDA review time
422 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K191574 | OxSAT 100 | S.L.P. , Ltd. | 2020-04-09 | 300 | 0 |
| K112822 | SLEEPSTRIP II | S.L.P. , Ltd. | 2011-12-27 | 90 | 0 |
| K080375 | RMX PHYSIOLOGICAL DATA RECORDER | S.L.P. , Ltd. | 2008-09-02 | 203 | 0 |
| K042253 | SLEEPSENSE SLEEP SENSORS | S.L.P. , Ltd. | 2004-10-06 | 47 | 0 |
| K030869 | BITESTRIP | S.L.P. , Ltd. | 2004-05-14 | 422 | 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