Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Testing System, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
157 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K801799 | ATRIAL/VENTRICULAR SEQENTIAL #080-20000 | Medical Testing System, Inc. | 1981-01-02 | 157 | 0 |
| K801802 | ELECTROMAGNETIC BLOOD & ARTERIAL GAUGE | Medical Testing System, Inc. | 1981-01-02 | 157 | 0 |
| K801800 | UNIVERSAL TEMP. PACING ELECT. #080-10000 | Medical Testing System, Inc. | 1980-10-23 | 86 | 0 |
| K791797 | MTS CATHETER ADAPTER FOR GUIDANCE ENTRY | Medical Testing System, Inc. | 1979-10-11 | 27 | 0 |
| K770641 | MINI-CONER TM | Medical Testing System, Inc. | 1977-06-24 | 81 | 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