Prizm Medical, Inc.: FDA clearances and approvals
Prizm Medical, Inc. has 8 FDA 510(k) clearances (first 1994, latest 2014), across 5 product codes in 3 review panels. Median 510(k) review time: 326 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 384 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 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 |
|---|---|---|---|
| GXY | Electrode, Cutaneous | 2 | 2 |
| IPF | Stimulator, Muscle, Powered | 2 | 2 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 2 | 2 |
| FLL | Continuous Measurement Thermometer | 1 | 1 |
| GYB | Media, Electroconductive | 1 | 1 |
Review panels
- Neurology (5)
- Physical Medicine (2)
- General Hospital (1)
Most recent Prizm Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133502 | 5000Z FIREFLY SYSTEM | NUH | 2014-12-03 | 384 |
| K033122 | 5000Z SYSTEM (OTC) | NUH | 2004-08-25 | 330 |
| K032239 | THERA-CREAM, MODEL TCT004 | GYB | 2004-07-30 | 375 |
| K024181 | PRIZM MEDICAL, INC. MICRO-Z STIMULATION SYSTEM | IPF | 2003-06-26 | 189 |
| K012974 | PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007 | FLL | 2002-07-23 | 321 |
| K951727 | Z-WATCH SYSTEM | IPF | 1995-11-21 | 222 |
| K944487 | ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODES | GXY | 1995-02-21 | 161 |
| K932299 | ELECTRO-MESH | GXY | 1994-07-01 | 416 |
Recalls
openFDA lists no recalls under a recalling firm named Prizm Medical, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Prizm Medical, Inc. have?
Prizm Medical, Inc. has 8 FDA 510(k) clearances (first 1994, latest 2014), across 5 product codes in 3 review panels.
How long does FDA take to clear Prizm Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Prizm Medical, Inc.'s cleared 510(k)s is 326 days.
What devices does Prizm Medical, Inc. make?
Its most frequent FDA product codes are GXY (Electrode, Cutaneous, 2); IPF (Stimulator, Muscle, Powered, 2); NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter, 2).
Has Prizm Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Prizm Medical, Inc. Related entities may recall under other names.
Next steps
- See all 8 Prizm Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GXY, Prizm Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.