Proverum Limited: FDA filings under this applicant name
FDA lists 1 510(k) clearance under 2 spellings of the applicant name “Proverum Limited” (first 2025, latest 2025), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 110 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 |
|---|---|---|
| 2025 | 1 | 110 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Proverum Limited took a median 110 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 110 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 1 | 1 |
| MER | Stent, Urethral, Prostatic, Permanent Or Semi-Permanent | 1 | 0 |
Review panels
Most recent Proverum Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251734 | ProVee Video Processing Unit (PV-003) | FET | 2025-09-24 | 110 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250011 | PMA | ProVee System for BPH | 2025-12-09 |
Recalls
openFDA lists no recalls under a recalling firm named Proverum Limited.
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.
FDA spellings included
FDA records this applicant under 2 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Proverum Limited (1)
- Proverum, Ltd. (1)
Frequently asked questions
How many FDA 510(k) clearances are listed under Proverum Limited?
FDA lists 1 510(k) clearance under 2 spellings of the applicant name “Proverum Limited” (first 2025, latest 2025), 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 Proverum Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Proverum Limited is 110 days.
Which FDA product codes appear under Proverum Limited?
The most frequent FDA product codes under this applicant name are FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology, 1); MER (Stent, Urethral, Prostatic, Permanent Or Semi-Permanent, 1).
Next steps
- See all 1 Proverum Limited clearances with predicates and recalls
- Run predicate analysis for product code FET, Proverum Limited'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.