Math Resolutions, LLC: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Math Resolutions, LLC” (first 2001, latest 2016), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 86 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 86 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 64 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 6 | 6 |
| MUJ | System, Planning, Radiation Therapy Treatment | 1 | 1 |
Review panels
- Radiology (7)
Most recent Math Resolutions, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162577 | Dosimetry Check Version 5 Release 1 | IYE | 2016-11-18 | 64 |
| K132605 | DOSIMETRY CHECK VERSION 4 RELEASE 1 | IYE | 2013-11-14 | 86 |
| K101503 | DUSIMETRY CHECK | IYE | 2010-08-04 | 64 |
| K050372 | VISITRAK, VERSION 1, RELEASE 1 | IYE | 2005-03-25 | 39 |
| K022961 | RTDOSEPLAN | MUJ | 2003-01-31 | 147 |
| K011845 | MILLCOMP | IYE | 2001-12-04 | 175 |
| K010225 | DOSIMETRY CHECK | IYE | 2001-04-24 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Math Resolutions, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Math Solutions, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Math Resolutions, LLC?
FDA lists 7 510(k) clearances under the applicant name “Math Resolutions, LLC” (first 2001, latest 2016), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Math Resolutions, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Math Resolutions, LLC is 86 days.
Which FDA product codes appear under Math Resolutions, LLC?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 6); MUJ (System, Planning, Radiation Therapy Treatment, 1).
Next steps
- See all 7 Math Resolutions, LLC clearances with predicates and recalls
- Run predicate analysis for product code IYE, Math Resolutions, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.