Zenflow, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Zenflow, Inc.” (first 2025, latest 2025), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 162 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 | 162 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Zenflow, Inc. took a median 162 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 140 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 | 1 |
| MER | Stent, Urethral, Prostatic, Permanent Or Semi-Permanent | 1 | 0 |
Review panels
Most recent Zenflow, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251140 | Zenflow Spring Scope | FAJ | 2025-09-23 | 162 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250007 | PMA | Zenflow Spring® Implant and Delivery System | 2025-12-11 |
Recalls
openFDA lists no recalls under a recalling firm named Zenflow, Inc..
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 Zenflow, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT04987138: Safety and Effectiveness Study of the Zenflow Spring System (Active not recruiting, started 2021-09-30)
Frequently asked questions
How many FDA 510(k) clearances are listed under Zenflow, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Zenflow, Inc.” (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 Zenflow, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Zenflow, Inc. is 162 days.
Which FDA product codes appear under Zenflow, Inc.?
The most frequent FDA product codes under this applicant name are FAJ (Cystoscope And Accessories, Flexible/Rigid, 1); MER (Stent, Urethral, Prostatic, Permanent Or Semi-Permanent, 1).
Next steps
- See all 1 Zenflow, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FAJ, Zenflow, Inc.'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.