Inovise Medical, Inc.: FDA clearances and approvals
Inovise Medical, Inc. has 14 FDA 510(k) clearances (first 2000, latest 2016), across 6 product codes in 2 review panels. Median 510(k) review time: 198 days. openFDA lists 1 product recall by a recalling firm named Inovise Medical, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 218 |
| 2013 | 1 | 213 |
| 2014 | 1 | 290 |
| 2015 | 0 | — |
| 2016 | 1 | 295 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DPS | Electrocardiograph | 3 | 3 |
| MLO | Electrocardiograph, Ambulatory, With Analysis Algorithm | 3 | 3 |
| DQD | Stethoscope, Electronic | 2 | 2 |
| DRX | Electrode, Electrocardiograph | 2 | 2 |
| MNR | Ventilatory Effort Recorder | 2 | 2 |
| MWJ | Electrocardiograph, Ambulatory (Without Analysis) | 2 | 2 |
Review panels
- Cardiovascular (12)
- Anesthesiology (2)
Most recent Inovise Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K151433 | AUDICOR CA300/CC100 Analyzer with SDB | MNR | 2016-03-18 | 295 |
| K131883 | AUDICOR CPAM WITH SDB (ACCELEROMETER BASED) | MNR | 2014-04-11 | 290 |
| K130660 | AUDICOR CPAM WITH SDB (SINGLE SENSOR) | MLO | 2013-10-11 | 213 |
| K120462 | AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION) | MLO | 2012-09-20 | 218 |
| K110569 | AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR) | MLO | 2011-10-24 | 238 |
| K103516 | AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0 | DQD | 2011-02-04 | 66 |
| K080602 | AUDICOR SENSOR, MODELS: 2.0, 3.0 | DRX | 2008-09-25 | 206 |
| K073545 | AUDICOR, HEMO AMBULATORY MONITOR | MWJ | 2008-09-09 | 266 |
| K070136 | AUDICOR 200 SYSTEM, MODELS 200D AND 200S | DPS | 2007-04-13 | 87 |
| K051450 | EXTENDED MEASUREMENTS SYSTEM | DQD | 2005-11-10 | 161 |
4 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2003-01-12.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Inovise Medical, Inc. have?
Inovise Medical, Inc. has 14 FDA 510(k) clearances (first 2000, latest 2016), across 6 product codes in 2 review panels.
How long does FDA take to clear Inovise Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Inovise Medical, Inc.'s cleared 510(k)s is 198 days.
What devices does Inovise Medical, Inc. make?
Its most frequent FDA product codes are DPS (Electrocardiograph, 3); MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm, 3); DQD (Stethoscope, Electronic, 2).
Has Inovise Medical, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Inovise Medical, Inc; the most recent began 2003-01-12. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 14 Inovise Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DPS, Inovise Medical, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.