H.S Hospital Service S.P.A: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “H.S Hospital Service S.P.A” (first 2004, latest 2024), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 222 days. Since 2017 the median was 212 days, against 114 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 233 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 402 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 151 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name H.S Hospital Service S.P.A took a median 212 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 114 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 3 | 3 |
| KNW | Instrument, Biopsy | 2 | 2 |
| NEY | System, Ablation, Microwave And Accessories | 1 | 1 |
Review panels
Most recent H.S Hospital Service S.P.A 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K242029 | TRAP EASY | KNW | 2024-10-09 | 90 |
| K232072 | AMICA-GEN AGN-H-1.3, AMICA-GEN AGN 3.3, AMICA-PROBE 17G & 18G | GEI | 2024-02-09 | 212 |
| K182605 | HS AMICA devices family | GEI | 2019-10-28 | 402 |
| K150112 | HS AMICA DEVICES FAMILY | GEI | 2015-09-10 | 233 |
| K083157 | HS AMICA | NEY | 2009-09-29 | 340 |
| K033616 | TRAPMATIC SYSTEM SET | KNW | 2004-03-01 | 105 |
Recalls
openFDA lists no recalls under a recalling firm named H.S Hospital Service S.P.A.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under H.S Hospital Service S.P.A?
FDA lists 6 510(k) clearances under the applicant name “H.S Hospital Service S.P.A” (first 2004, latest 2024), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by H.S Hospital Service S.P.A?
The median time from FDA receipt to decision across 510(k)s cleared under the name H.S Hospital Service S.P.A is 222 days. Since 2017: 212 days, versus 114 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under H.S Hospital Service S.P.A?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 3); KNW (Instrument, Biopsy, 2); NEY (System, Ablation, Microwave And Accessories, 1).
Next steps
- See all 6 H.S Hospital Service S.P.A clearances with predicates and recalls
- Run predicate analysis for product code GEI, H.S Hospital Service S.P.A's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.