Spes Medica Srl: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Spes Medica Srl” (first 2009, latest 2022), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 128 days. Since 2017 the median was 128 days, against 132 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 | 1 | 115 |
| 2013 | 0 | — |
| 2014 | 1 | 387 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 2 | 126 |
| 2020 | 1 | 119 |
| 2021 | 1 | 128 |
| 2022 | 1 | 505 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Spes Medica Srl took a median 128 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 132 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GYB | Media, Electroconductive | 3 | 3 |
| ETN | Stimulator, Nerve | 2 | 2 |
| GXY | Electrode, Cutaneous | 1 | 1 |
| GXZ | Electrode, Needle | 1 | 1 |
| GYC | Electrode, Cortical | 1 | 1 |
| IKT | Electrode, Needle, Diagnostic Electromyograph | 1 | 1 |
Review panels
- Neurology (7)
- Ear, Nose and Throat (2)
Most recent Spes Medica Srl 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K211954 | Subdural Electrode, Strip/Intraoperative Strip, Grid/Intraoperative Grid, Multi-Strip and Split Grid, Intraoperative Mapping Grid | GYC | 2022-11-10 | 505 |
| K212326 | AC Cream - Conductive paste | GYB | 2021-12-01 | 128 |
| K192606 | SAC2 - Electrode Cream | GYB | 2020-01-17 | 119 |
| K192603 | Spes Medica Subdermal Needle Electrodes | GXZ | 2019-11-22 | 63 |
| K190050 | Tech Dots - Adhesive and conductive gel | GYB | 2019-07-19 | 190 |
| K133348 | STIM PROBE | ETN | 2014-11-21 | 387 |
| K120494 | DISPOSABLE ADHESIVE SURFACE ELECTRODE | GXY | 2012-06-11 | 115 |
| K093373 | LARYNGEAL SURFACE ELECTRODE | ETN | 2010-08-24 | 299 |
| K091410 | DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT, | IKT | 2009-08-11 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Spes Medica Srl.
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 Spes Medica Srl?
FDA lists 9 510(k) clearances under the applicant name “Spes Medica Srl” (first 2009, latest 2022), across 6 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 Spes Medica Srl?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spes Medica Srl is 128 days. Since 2017: 128 days, versus 132 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Spes Medica Srl?
The most frequent FDA product codes under this applicant name are GYB (Media, Electroconductive, 3); ETN (Stimulator, Nerve, 2); GXY (Electrode, Cutaneous, 1).
Next steps
- See all 9 Spes Medica Srl clearances with predicates and recalls
- Run predicate analysis for product code GYB, Spes Medica Srl'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.