Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LimFlow, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
96 daysmedian FDA review time
174 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260188 | LimFlow Vector | LimFlow, Inc. | 2026-03-18 | 55 | 0 |
| K251376 | LimFlow ARC | LimFlow, Inc. | 2025-05-31 | 29 | 0 |
| K242776 | LimFlow V-Ceiver | LimFlow, Inc. | 2025-02-14 | 154 | 0 |
| K221902 | LimFlow Vector | LimFlow, Inc. | 2022-12-21 | 174 | 1 |
| K221541 | LimFlow ARC | LimFlow, Inc. | 2022-08-31 | 96 | 0 |
| K222083 | LimFlow V-Ceiver | LimFlow, Inc. | 2022-08-09 | 25 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda