Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical & Scientific Designs, Inc. · Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
48 daysmedian FDA review time
85 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K862960 | PHASE II FERRITIN RADIOIMMUNOASSAY KIT | Medical & Scientific Designs, Inc. | 1986-08-27 | 22 | 0 |
| K853224 | PHASE II B-12/FOLATE KIT | Medical & Scientific Designs, Inc. | 1985-10-03 | 63 | 0 |
| K840901 | PHASE II FREE T4 KIT | Medical & Scientific Designs, Inc. | 1984-04-25 | 57 | 0 |
| K840328 | PHASE II HCG KIT | Medical & Scientific Designs, Inc. | 1984-04-19 | 85 | 0 |
| K834219 | PHASE II CORTISOL KIT | Medical & Scientific Designs, Inc. | 1984-02-04 | 61 | 0 |
| K833789 | PHASE II THEOPHYLLINE RADIOIMMUNOASSAY | Medical & Scientific Designs, Inc. | 1984-01-24 | 85 | 0 |
| K832499 | PHASE II TSH KIT | Medical & Scientific Designs, Inc. | 1983-09-12 | 47 | 0 |
| K832210 | GAMMA PHOTON GAMMA COUNTER | Medical & Scientific Designs, Inc. | 1983-08-24 | 48 | 0 |
| K832209 | KINETI COUNT 24 GAMMA COUNTER | Medical & Scientific Designs, Inc. | 1983-08-24 | 48 | 0 |
| K831064 | PHASE II T3 RADIOIMMUNOASSAY KIT | Medical & Scientific Designs, Inc. | 1983-05-09 | 35 | 0 |
| K830900 | UPTAKE T3 RADIOIMMUNOASSAY KIT | Medical & Scientific Designs, Inc. | 1983-04-18 | 28 | 0 |
| K830533 | PHASE II DIGOXIN RADIOIMMUNOASSAY KIT | Medical & Scientific Designs, Inc. | 1983-04-05 | 46 | 0 |
| K830642 | PHASE THYROXINE RADIOIMMUNOASSAY KIT | Medical & Scientific Designs, Inc. | 1983-04-05 | 35 | 0 |
| K830365 | KINETI COUNT 48 IMMUNOASSAY SYSTEM | Medical & Scientific Designs, Inc. | 1983-03-10 | 34 | 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