Nuance Medical, LLC: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Nuance Medical, LLC” (first 2013, latest 2024), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 98 days. Since 2017 the median was 164 days, against 93 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 1 | 65 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 2 | 83 |
| 2017 | 1 | 89 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 261 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 164 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Nuance Medical, LLC took a median 164 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 93 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEH | Unit, Cryosurgical, Accessories | 3 | 3 |
| MLY | Vapocoolant Device | 3 | 3 |
Review panels
Most recent Nuance Medical, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232674 | PainFreeze II | MLY | 2024-02-12 | 164 |
| K210310 | CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit | GEH | 2021-10-22 | 261 |
| K172203 | CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray | MLY | 2017-10-18 | 89 |
| K162218 | Pain Freeze, Medium Stream Spray, Model #2101; Pain Freeze, Mist Spray, Model #2102 | MLY | 2016-11-22 | 106 |
| K161337 | CryoDose H or Similar | GEH | 2016-07-12 | 60 |
| K130995 | NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY | GEH | 2013-06-14 | 65 |
Recalls
openFDA lists no recalls under a recalling firm named Nuance Medical, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Nuance Medical, LLC?
FDA lists 6 510(k) clearances under the applicant name “Nuance Medical, LLC” (first 2013, latest 2024), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Nuance Medical, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nuance Medical, LLC is 98 days. Since 2017: 164 days, versus 93 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Nuance Medical, LLC?
The most frequent FDA product codes under this applicant name are GEH (Unit, Cryosurgical, Accessories, 3); MLY (Vapocoolant Device, 3).
Next steps
- See all 6 Nuance Medical, LLC clearances with predicates and recalls
- Run predicate analysis for product code GEH, Nuance Medical, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.