Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Miramar Labs, Inc. · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
176 daysmedian FDA review time
284 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K180396 | miraDry System | Miramar Labs, Inc. | 2018-03-15 | 30 | 0 |
| K160141 | miraDry System | Miramar Labs, Inc. | 2016-10-31 | 284 | 0 |
| K150419 | miraDry System MD4000 | Miramar Labs, Inc. | 2015-06-19 | 121 | 1 |
| K131162 | MIRADRY SYSTEM | Miramar Labs, Inc. | 2013-10-25 | 184 | 1 |
| K103014 | MIRADRY SYSTEM | Miramar Labs, Inc. | 2011-01-28 | 107 | 2 |
| K082819 | DERMATOLOGIC TREATMENT SYSTEM (DTS) G2 | Miramar Labs, Inc. | 2009-03-20 | 176 | 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