Predicate Research Report · generated 2026-08-24 · Print / save as PDF · Save to account
Inovise Medical, Inc. · Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
206 daysmedian FDA review time
290 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K151433 | AUDICOR CA300/CC100 Analyzer with SDB | Inovise Medical, Inc. | 2016-03-18 | 295 | 0 |
| K131883 | AUDICOR CPAM WITH SDB (ACCELEROMETER BASED) | Inovise Medical, Inc. | 2014-04-11 | 290 | 0 |
| K130660 | AUDICOR CPAM WITH SDB (SINGLE SENSOR) | Inovise Medical, Inc. | 2013-10-11 | 213 | 0 |
| K120462 | AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WI | Inovise Medical, Inc. | 2012-09-20 | 218 | 0 |
| K110569 | AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) | Inovise Medical, Inc. | 2011-10-24 | 238 | 0 |
| K103516 | AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0 | Inovise Medical, Inc. | 2011-02-04 | 66 | 0 |
| K080602 | AUDICOR SENSOR, MODELS: 2.0, 3.0 | Inovise Medical, Inc. | 2008-09-25 | 206 | 0 |
| K073545 | AUDICOR, HEMO AMBULATORY MONITOR | Inovise Medical, Inc. | 2008-09-09 | 266 | 0 |
| K070136 | AUDICOR 200 SYSTEM, MODELS 200D AND 200S | Inovise Medical, Inc. | 2007-04-13 | 87 | 0 |
| K051450 | EXTENDED MEASUREMENTS SYSTEM | Inovise Medical, Inc. | 2005-11-10 | 161 | 0 |
| K043074 | LIBERTY SYSTEM | Inovise Medical, Inc. | 2005-02-22 | 106 | 1 |
| K032145 | AUDICOR UPGRADE SYSTEM | Inovise Medical, Inc. | 2003-10-31 | 109 | 0 |
| K030316 | AUDICOR COR SENSOR (AND ACCESSORY ADAPTOR) | Inovise Medical, Inc. | 2003-08-07 | 189 | 0 |
| K001349 | CARDIOVISE ECG INTERPRETATIVE SOFTWARE | Inovise Medical, Inc. | 2000-07-27 | 90 | 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