Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nuance Medical, LLC — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
106 daysmedian FDA review time
261 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232674 | PainFreeze II | Nuance Medical, LLC | 2024-02-12 | 164 | 0 |
| K210310 | CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236m | Nuance Medical, LLC | 2021-10-22 | 261 | 0 |
| K172203 | CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray | Nuance Medical, LLC | 2017-10-18 | 89 | 0 |
| K162218 | Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™ | Nuance Medical, LLC | 2016-11-22 | 106 | 0 |
| K161337 | CryoDose H or Similar | Nuance Medical, LLC | 2016-07-12 | 60 | 0 |
| K130995 | NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE | Nuance Medical, LLC | 2013-06-14 | 65 | 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