Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Marquette Medical Systems, Inc. · Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
201 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K993008 | QUANTITATIVE SENTINEL SYSTEM | Marquette Medical Systems, Inc. | 1999-12-06 | 90 | 3 |
| K981024 | QT DISPERSION AND T WAVE ANALYSIS PROGRAM (QT GUARD ANALYSIS | Marquette Medical Systems, Inc. | 1998-10-06 | 201 | 0 |
| K980495 | MUSE CARDIOVASCULAR INFORMATION SYSTEM | Marquette Medical Systems, Inc. | 1998-05-07 | 87 | 0 |
| K980299 | APEX OXIMETER | Marquette Medical Systems, Inc. | 1998-04-24 | 87 | 1 |
| K980582 | MULTI-LINK CABLE AND LEAD WIRE SYSTEMS | Marquette Medical Systems, Inc. | 1998-03-16 | 27 | 0 |
| K973403 | CARDIOSMART ST | Marquette Medical Systems, Inc. | 1998-03-12 | 184 | 0 |
| K974199 | ACUTE CARDIAC ISCHEMIA TIME-INSENSITIVE PREDICTIVE INSTRUMEN | Marquette Medical Systems, Inc. | 1998-02-06 | 88 | 0 |
| K973984 | RAC 2A MODULE HOUSING | Marquette Medical Systems, Inc. | 1998-01-16 | 88 | 0 |
| K970545 | DASH 1000 PATIENT MONITOR | Marquette Medical Systems, Inc. | 1997-05-08 | 85 | 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