Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Myoscience, Inc. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
115 daysmedian FDA review time
262 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K173763 | iovera system | Myoscience, Inc. | 2018-02-28 | 79 | 0 |
| K161835 | iovera system | Myoscience, Inc. | 2017-03-24 | 262 | 0 |
| K142866 | Myoscience iovera system | Myoscience, Inc. | 2015-01-21 | 112 | 1 |
| K133453 | IOVERA | Myoscience, Inc. | 2014-03-24 | 132 | 0 |
| K123516 | CRYO-TOUCH IV | Myoscience, Inc. | 2013-01-10 | 57 | 1 |
| K120415 | CRYO-TOUCH III | Myoscience, Inc. | 2012-06-22 | 133 | 0 |
| K102021 | CRYO-TOUCH II | Myoscience, Inc. | 2010-09-17 | 60 | 0 |
| K100447 | MYOSCIENCE CRYO-TOUCH | Myoscience, Inc. | 2010-06-25 | 128 | 0 |
| K083493 | MYOSCIENCE CRYO-TOUCH | Myoscience, Inc. | 2009-03-20 | 115 | 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