Prisma Systems: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Prisma Systems” (first 1994, latest 1995), across 26 product codes in 1 review panel. Median 510(k) review time under this name: 165 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 | 0 | — |
| 2014 | 0 | — |
| 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 |
|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | 2 | 2 |
| CDN | Urease, Photometric, Urea Nitrogen | 1 | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
| CEJ | Tetraphenyl Borate, Colorimetry, Potassium | 1 | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 | 1 |
| CFR | Hexokinase, Glucose | 1 | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
Plus 16 more product codes.
Review panels
- Clinical Chemistry (27)
Most recent Prisma Systems 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K950177 | CK QVET | CGS | 1995-03-03 | 45 |
| K943027 | CHOLESTEROL QVET | CHH | 1995-01-27 | 214 |
| K943042 | BUN QVET | CDN | 1994-12-29 | 185 |
| K943001 | MAGNESIUM QVET | JGJ | 1994-12-29 | 189 |
| K942997 | ALKALINE PHOSPHATASE (ALKP) QVET | CJE | 1994-12-29 | 189 |
| K942964 | LACTATE DEHYDROGENASE QVET | CFJ | 1994-12-29 | 189 |
| K942963 | GLUCOSE QVET | CFR | 1994-12-29 | 189 |
| K944102 | AST QVET | CIT | 1994-12-13 | 112 |
| K943000 | ALBUMIN QVET | CIX | 1994-12-13 | 173 |
| K943026 | POTASSIUM QVET | CEJ | 1994-12-09 | 165 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Prisma Systems.
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 Prisma Systems?
FDA lists 27 510(k) clearances under the applicant name “Prisma Systems” (first 1994, latest 1995), across 26 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 Prisma Systems?
The median time from FDA receipt to decision across 510(k)s cleared under the name Prisma Systems is 165 days.
Which FDA product codes appear under Prisma Systems?
The most frequent FDA product codes under this applicant name are CIG (Diazo Colorimetry, Bilirubin, 2); CDN (Urease, Photometric, Urea Nitrogen, 1); CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 1).
Next steps
- See all 27 Prisma Systems clearances with predicates and recalls
- Run predicate analysis for product code CIG, Prisma Systems'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.