Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Magnetic Resonance Equipment Corp. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
259 daysmedian FDA review time
579 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K003982 | TEMPERATURE FUNCTION, MODEL 9500 MULTIGAS MONITOR | Magnetic Resonance Equipment Corp. | 2001-01-26 | 35 | 0 |
| K983250 | INVASIVE BLOOD PRESSURE (IBP) FUNCTION, MODEL 9500 MULTIGAS | Magnetic Resonance Equipment Corp. | 1999-12-12 | 452 | 1 |
| K954120 | MODEL 9500 MR-COMPATIBLE MULTIGAS MONITOR | Magnetic Resonance Equipment Corp. | 1997-04-02 | 579 | 0 |
| K924285 | MODEL 3500 MR-COMPATIBLE PULSE OXIMETER | Magnetic Resonance Equipment Corp. | 1993-05-11 | 259 | 0 |
| K924282 | MODEL 320 MR-COMPATIBLE PULSE OXIMETER | Magnetic Resonance Equipment Corp. | 1993-05-07 | 255 | 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