Liofilchem s.r.l.: FDA filings under this applicant name
FDA lists 35 510(k) clearances under the applicant name “Liofilchem s.r.l.” (first 2016, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 62 days. Since 2017 the median was 59 days, against 71 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 |
|---|---|---|
| 2016 | 4 | 88 |
| 2017 | 8 | 69 |
| 2018 | 9 | 46 |
| 2019 | 7 | 51 |
| 2020 | 1 | 56 |
| 2021 | 1 | 141 |
| 2022 | 0 | — |
| 2023 | 1 | 85 |
| 2024 | 0 | — |
| 2025 | 3 | 89 |
| 2026 | 1 | 45 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Liofilchem s.r.l. took a median 59 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 71 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | 35 | 35 |
Review panels
- Microbiology (35)
Most recent Liofilchem s.r.l. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260696 | MTS Gepotidacin 0.016-256 µg/mL | JWY | 2026-04-17 | 45 |
| K252114 | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL | JWY | 2025-10-02 | 87 |
| K251580 | MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD) | JWY | 2025-08-20 | 89 |
| K243202 | MTS Ceftobiprole 0.002-32 µg/mL | JWY | 2025-01-30 | 121 |
| K230479 | ComASP Cefiderocol 0.008-128 | JWY | 2023-05-18 | 85 |
| K211672 | MTS Piperacillin-tazobactam 0.016/4 - 256/4µg/mL | JWY | 2021-10-20 | 141 |
| K200180 | MTS Omadacycline 0.002 - 32 ug/mL | JWY | 2020-03-20 | 56 |
| K192345 | MTS Ampicillin-Sulbactam 0.016/0.008 - 256/128 µg/mL | JWY | 2019-10-31 | 63 |
| K191908 | MTS Imipenem 0.016-256 µg/mL | JWY | 2019-09-04 | 50 |
| K191809 | MTS Imipenem-relebactam 0.002/4-32/4 µg/mL | JWY | 2019-08-23 | 49 |
25 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Liofilchem s.r.l..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Liofilchem, Inc. (3 510(k)s)
- Liofilchem S. R. 1. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Liofilchem s.r.l.?
FDA lists 35 510(k) clearances under the applicant name “Liofilchem s.r.l.” (first 2016, latest 2026), across 1 product code 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 Liofilchem s.r.l.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Liofilchem s.r.l. is 62 days. Since 2017: 59 days, versus 71 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Liofilchem s.r.l.?
The most frequent FDA product codes under this applicant name are JWY (Manual Antimicrobial Susceptibility Test Systems, 35).
Next steps
- See all 35 Liofilchem s.r.l. clearances with predicates and recalls
- Run predicate analysis for product code JWY, Liofilchem s.r.l.'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.