Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
H.S Hospital Service S.P.A · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
233 daysmedian FDA review time
402 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242029 | TRAP EASY | H.S Hospital Service S.P.A | 2024-10-09 | 90 | 0 |
| K232072 | AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18 | H.S Hospital Service S.P.A | 2024-02-09 | 212 | 0 |
| K182605 | HS AMICA devices family | H.S Hospital Service S.P.A | 2019-10-28 | 402 | 0 |
| K150112 | HS AMICA DEVICES FAMILY | H.S Hospital Service S.P.A | 2015-09-10 | 233 | 0 |
| K083157 | HS AMICA | H.S Hospital Service S.P.A | 2009-09-29 | 340 | 0 |
| K033616 | TRAPMATIC SYSTEM SET | H.S Hospital Service S.P.A | 2004-03-01 | 105 | 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