Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Parameters, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
69 daysmedian FDA review time
155 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K862190 | WALRUS: DOUBLE BALLOON SHUNTING CATHETER | Medical Parameters, Inc. | 1986-11-03 | 147 | 0 |
| K844444 | ESOPHAGEAL STETHOSCOPE | Medical Parameters, Inc. | 1985-01-10 | 55 | 0 |
| K833825 | MULTI-LUMEN INTRAVENOUS INFUSION CATH | Medical Parameters, Inc. | 1984-01-10 | 69 | 0 |
| K830754 | BLOOD PRESSURE MONITORING KITS,WALRUS | Medical Parameters, Inc. | 1983-08-12 | 155 | 0 |
| K831239 | WALRUS PERCUTANEOUS INTRODUCER SET | Medical Parameters, Inc. | 1983-05-25 | 40 | 0 |
| K830755 | I.V. SETS WALRUS BRAND VARIOUS CONFIGUR- | Medical Parameters, Inc. | 1983-04-28 | 49 | 21 |
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