Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Systems Corp. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
99 daysmedian FDA review time
302 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K931736 | M-FLEX 5000 C3PMD | Medical Systems Corp. | 1994-01-27 | 295 | 0 |
| K921513 | SPIROLITE MODEL MSC-201 SPIROMETER | Medical Systems Corp. | 1993-01-27 | 302 | 0 |
| K921485 | LA MONT VIDEO PATIENT MONITORING SYSTEM | Medical Systems Corp. | 1992-10-22 | 206 | 0 |
| K904353 | CARDIOMATIC MODEL MSC-2001 | Medical Systems Corp. | 1990-12-20 | 87 | 0 |
| K903501 | RADIANT TEMPERATUR INDICATOR MODEL 25E | Medical Systems Corp. | 1990-09-12 | 40 | 0 |
| K902192 | MODEL MSC SA02-5000 PULSE OXIMETER | Medical Systems Corp. | 1990-08-23 | 99 | 0 |
| K902608 | CARDIOMATIC MODEL MSC-1001 | Medical Systems Corp. | 1990-07-13 | 31 | 0 |
| K770878 | SIGNAL PROCESSOR/AVERAGER MODEL 7S11 | Medical Systems Corp. | 1977-06-01 | 20 | 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