Cane S.R.L.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Cane S.R.L.” (first 2001, latest 2009), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 44 days. 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 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRN | Pump, Infusion | 8 | 8 |
| LZG | Pump, Infusion, Insulin | 1 | 1 |
| MEA | Pump, Infusion, Pca | 1 | 1 |
Review panels
Most recent Cane S.R.L. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K091042 | CRONO S-PID 50 | FRN | 2009-05-12 | 29 |
| K052218 | CRONO FIVE AND CRONO PCA 50 | FRN | 2005-11-23 | 100 |
| K052219 | CRONO GO. | FRN | 2005-09-13 | 29 |
| K052217 | CRONO SUPER PID | FRN | 2005-09-13 | 29 |
| K042085 | CRONO F | FRN | 2004-09-17 | 45 |
| K041414 | CRONO AND CRONO, MODEL 30 | FRN | 2004-07-08 | 42 |
| K013840 | MICROJET CRONO PAR AND CRONO APO-GO | FRN | 2002-05-14 | 176 |
| K013822 | MICROJET CRONO PCA | MEA | 2002-05-08 | 173 |
| K013234 | MICROJET CRONO | FRN | 2002-04-26 | 211 |
| K013807 | MICROJET QUARK, MODEL U100 OR U40 | LZG | 2001-12-12 | 27 |
Recalls
openFDA lists no recalls under a recalling firm named Cane 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Cane S.R.L. (a text match, not an official crosswalk):
- A4220 — Refill kit for implantable infusion pump (via FRN)
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via FRN)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via FRN)
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.
- Cane S.R.I. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cane S.R.L.?
FDA lists 10 510(k) clearances under the applicant name “Cane S.R.L.” (first 2001, latest 2009), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cane S.R.L.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cane S.R.L. is 44 days.
Which FDA product codes appear under Cane S.R.L.?
The most frequent FDA product codes under this applicant name are FRN (Pump, Infusion, 8); LZG (Pump, Infusion, Insulin, 1); MEA (Pump, Infusion, Pca, 1).
Next steps
- See all 10 Cane S.R.L. clearances with predicates and recalls
- Run predicate analysis for product code FRN, Cane 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.