Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
S.A.L.F. Spa — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
240 daysmedian FDA review time
339 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230193 | Servator P Plus SALF Solution | S.A.L.F. Spa | 2023-09-21 | 240 | 0 |
| K211842 | Servator M SALF Solution | S.A.L.F. Spa | 2021-12-20 | 188 | 0 |
| K202652 | Servator P SALF Solution with THAM | S.A.L.F. Spa | 2021-08-19 | 339 | 0 |
| K190063 | Servator C SALF Solution | S.A.L.F. Spa | 2019-08-14 | 211 | 0 |
| K180481 | Servator B SALF Solution | S.A.L.F. Spa | 2018-06-29 | 126 | 0 |
| K170150 | Servator H SALF solution-1000 ml PVC free bags, Servator H S | S.A.L.F. Spa | 2017-10-20 | 276 | 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