LimFlow, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “LimFlow, Inc.” (first 2022, latest 2026), plus 1 PMA decision, across 4 product codes in 1 review panel. Median 510(k) review time under this name: 76 days. Since 2017 the median was 76 days, against 144 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 |
|---|---|---|
| 2022 | 3 | 96 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 2 | 92 |
| 2026 | 1 | 55 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name LimFlow, Inc. took a median 76 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 144 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MGZ | Valvulotome | 2 | 2 |
| MMX | Device, Percutaneous Retrieval | 2 | 2 |
| PDU | Catheter For Crossing Total Occlusions | 2 | 2 |
| QWN | Stent Graft, Infrapopliteal, Venous Arterialization | 1 | 0 |
Review panels
- Cardiovascular (7)
Most recent LimFlow, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260188 | LimFlow Vector | MGZ | 2026-03-18 | 55 |
| K251376 | LimFlow ARC | PDU | 2025-05-31 | 29 |
| K242776 | LimFlow V-Ceiver | MMX | 2025-02-14 | 154 |
| K221902 | LimFlow Vector | MGZ | 2022-12-21 | 174 |
| K221541 | LimFlow ARC | PDU | 2022-08-31 | 96 |
| K222083 | LimFlow V-Ceiver | MMX | 2022-08-09 | 25 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P220025 | PMA | LimFlow System | 2023-09-11 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2025-12-05.
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 LimFlow, Inc. is the lead sponsor of 2 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT05313165: PROMISE III: Percutaneous Deep Vein Arterialization for the Treatment of Late-Stage Chronic Limb-Threatening Ischemia (Recruiting, started 2022-12-22)
- NCT03124875: PROMISE I Early Feasibility Trial of the LimFlow Stent Graft System (Completed, started 2017-07-05)
Frequently asked questions
How many FDA 510(k) clearances are listed under LimFlow, Inc.?
FDA lists 6 510(k) clearances under the applicant name “LimFlow, Inc.” (first 2022, latest 2026), plus 1 PMA decision, across 4 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 LimFlow, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name LimFlow, Inc. is 76 days. Since 2017: 76 days, versus 144 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under LimFlow, Inc.?
The most frequent FDA product codes under this applicant name are MGZ (Valvulotome, 2); MMX (Device, Percutaneous Retrieval, 2); PDU (Catheter For Crossing Total Occlusions, 2).
Next steps
- See all 6 LimFlow, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MGZ, LimFlow, 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.