Advanced Brain Monitoring, Inc.: FDA clearances and approvals
Advanced Brain Monitoring, Inc. has 15 FDA 510(k) clearances (first 2004, latest 2018), across 6 product codes in 4 review panels. Median 510(k) review time: 118 days. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 3 | 132 |
| 2013 | 3 | 105 |
| 2014 | 1 | 125 |
| 2015 | 1 | 100 |
| 2016 | 1 | 110 |
| 2017 | 0 | — |
| 2018 | 1 | 172 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Advanced Brain Monitoring, Inc.'s cleared 510(k)s took a median 172 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 165 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MNR | Ventilatory Effort Recorder | 6 | 6 |
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroencephalograph | 3 | 3 |
| OMC | Reduced- Montage Standard Electroencephalograph | 3 | 3 |
| GWQ | Full-Montage Standard Electroencephalograph | 1 | 1 |
| LRK | Device, Anti-Snoring | 1 | 1 |
| MYB | Pillow, Cervical (For Mild Sleep Apnea) | 1 | 1 |
Review panels
- Neurology (7)
- Anesthesiology (6)
- Dental (1)
- Ear, Nose and Throat (1)
Most recent Advanced Brain Monitoring, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K172799 | Positional Sleep Assessment System (PoSAS) software | MNR | 2018-03-09 | 172 |
| K153412 | Sleep Profiler | OLZ | 2016-03-14 | 110 |
| K152040 | X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29) | OMC | 2015-10-30 | 100 |
| K140190 | NIGHT SHIFT | MYB | 2014-05-29 | 125 |
| K131383 | X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE | GWQ | 2013-11-27 | 197 |
| K130007 | SLEEP PROFILER | OLZ | 2013-04-17 | 105 |
| K130013 | X4 SYSTEM | OMC | 2013-01-31 | 29 |
| K120450 | SLEEP PROFILER | OLZ | 2012-09-19 | 218 |
| K120447 | X4 | OMC | 2012-06-20 | 127 |
| K112514 | APNEA RISK EVALUATION SYSTEM (ARES) | MNR | 2012-01-09 | 132 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Advanced Brain Monitoring, Inc..
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.
Device clinical trials
Advanced Brain Monitoring, Inc. is the industry lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02032706: Validation of Safety and Efficacy for Night Shift Therapy (Completed, started 2013-06)
Frequently asked questions
How many FDA 510(k) clearances does Advanced Brain Monitoring, Inc. have?
Advanced Brain Monitoring, Inc. has 15 FDA 510(k) clearances (first 2004, latest 2018), across 6 product codes in 4 review panels.
How long does FDA take to clear Advanced Brain Monitoring, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Advanced Brain Monitoring, Inc.'s cleared 510(k)s is 118 days.
What devices does Advanced Brain Monitoring, Inc. make?
Its most frequent FDA product codes are MNR (Ventilatory Effort Recorder, 6); OLZ (Automatic Event Detection Software For Polysomnograph With Electroencephalograph, 3); OMC (Reduced- Montage Standard Electroencephalograph, 3).
Has Advanced Brain Monitoring, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Advanced Brain Monitoring, Inc. Related entities may recall under other names.
Next steps
- See all 15 Advanced Brain Monitoring, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MNR, Advanced Brain Monitoring, 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.