Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Luvo Medical Technologies, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
122 daysmedian FDA review time
205 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K212607 | Darwin | Luvo Medical Technologies, Inc. | 2021-11-15 | 90 | 0 |
| K210129 | RF Thermal System | Luvo Medical Technologies, Inc. | 2021-07-20 | 182 | 0 |
| K203728 | Darwin | Luvo Medical Technologies, Inc. | 2021-07-14 | 205 | 0 |
| K193446 | Bare: 808 | Luvo Medical Technologies, Inc. | 2020-03-10 | 89 | 0 |
| K193072 | Lucent : IPL | Luvo Medical Technologies, Inc. | 2020-03-05 | 122 | 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