Srs Medical: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Srs Medical” (first 2021, latest 2021), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 105 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 |
|---|---|---|
| 2021 | 1 | 105 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Srs Medical took a median 105 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 105 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FEN | Device, Cystometric, Hydraulic | 1 | 1 |
| NZC | Stent, Urethral, Prostatic, Semi-Permanent | 1 | 0 |
Review panels
Most recent Srs Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K212830 | CT3000Pro | FEN | 2021-12-21 | 105 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P060010 | PMA | THE SPANNER TEMPORARY PROSTATIC STENT | 2006-12-14 |
Recalls
openFDA lists no recalls under a recalling firm named Srs Medical.
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.
Device clinical trials
An industry sponsor named Srs Medical is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02643849: Use of The Spanner Temporary Prostatic Stent as an Alternative to a Urinary Catheter to Achieve Bladder Drainage in Men (Completed, started 2016-08)
Frequently asked questions
How many FDA 510(k) clearances are listed under Srs Medical?
FDA lists 1 510(k) clearance under the applicant name “Srs Medical” (first 2021, latest 2021), plus 1 PMA decision, across 2 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 Srs Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Srs Medical is 105 days.
Which FDA product codes appear under Srs Medical?
The most frequent FDA product codes under this applicant name are FEN (Device, Cystometric, Hydraulic, 1); NZC (Stent, Urethral, Prostatic, Semi-Permanent, 1).
Next steps
- See all 1 Srs Medical clearances with predicates and recalls
- Run predicate analysis for product code FEN, Srs Medical'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.