Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Prisma Systems — Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
165 daysmedian FDA review time
189 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K950177 | CK QVET | Prisma Systems | 1995-03-03 | 45 | 0 |
| K943027 | CHOLESTEROL QVET | Prisma Systems | 1995-01-27 | 214 | 0 |
| K942997 | ALKALINE PHOSPHATASE (ALKP) QVET | Prisma Systems | 1994-12-29 | 189 | 0 |
| K943042 | BUN QVET | Prisma Systems | 1994-12-29 | 185 | 0 |
| K942964 | LACTATE DEHYDROGENASE QVET | Prisma Systems | 1994-12-29 | 189 | 0 |
| K943001 | MAGNESIUM QVET | Prisma Systems | 1994-12-29 | 189 | 0 |
| K942963 | GLUCOSE QVET | Prisma Systems | 1994-12-29 | 189 | 0 |
| K944102 | AST QVET | Prisma Systems | 1994-12-13 | 112 | 0 |
| K943000 | ALBUMIN QVET | Prisma Systems | 1994-12-13 | 173 | 0 |
| K943004 | TOTAL PROTEIN QVET | Prisma Systems | 1994-12-09 | 169 | 0 |
| K942960 | PHOSPHATE QVET | Prisma Systems | 1994-12-09 | 169 | 0 |
| K942961 | AMYLASE QVET | Prisma Systems | 1994-12-09 | 169 | 0 |
| K943026 | POTASSIUM QVET | Prisma Systems | 1994-12-09 | 165 | 0 |
| K943003 | CALCIUM QVET | Prisma Systems | 1994-12-09 | 169 | 0 |
| K943006 | CHLORIDE QVET | Prisma Systems | 1994-12-07 | 167 | 0 |
| K943028 | HDL QVET | Prisma Systems | 1994-12-07 | 163 | 0 |
| K942962 | GGT QVET | Prisma Systems | 1994-12-07 | 167 | 0 |
| K942999 | BILIRUBIN(TOTAL) QVET | Prisma Systems | 1994-12-02 | 162 | 0 |
| K943029 | IRON QVET | Prisma Systems | 1994-12-02 | 158 | 0 |
| K943002 | URIC ACID QVET | Prisma Systems | 1994-12-02 | 162 | 0 |
| K944028 | PROCHEM CHEMISTRY ANALYZER | Prisma Systems | 1994-11-30 | 105 | 0 |
| K943012 | CALIBRATOR | Prisma Systems | 1994-11-28 | 157 | 0 |
| K943005 | CREATININE QVET | Prisma Systems | 1994-11-22 | 152 | 0 |
| K942998 | TRIGLYCERODES QVET | Prisma Systems | 1994-11-22 | 152 | 0 |
| K942949 | BILIRUBIN (DIRECT) QVET | Prisma Systems | 1994-11-22 | 152 | 0 |
| K944080 | ALT QVET | Prisma Systems | 1994-11-22 | 92 | 0 |
| K944059 | PROCHEQ 1 & 2 | Prisma Systems | 1994-11-15 | 88 | 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