Aspect Medical Systems, Inc.: FDA clearances and approvals
Aspect Medical Systems, Inc. has 25 FDA 510(k) clearances (first 1992, latest 2009), across 5 product codes in 2 review panels. Median 510(k) review time: 28 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 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 |
|---|---|---|---|
| OLW | Index-Generating Electroencephalograph Software | 12 | 12 |
| GXY | Electrode, Cutaneous | 9 | 9 |
| OLT | Non-Normalizing Quantitative Electroencephalograph Software | 2 | 2 |
| DRX | Electrode, Electrocardiograph | 1 | 1 |
| GWY | Pinwheel | 1 | 1 |
Review panels
- Neurology (24)
- Cardiovascular (1)
Most recent Aspect Medical Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093183 | BIS QUATRO SENSOR | GXY | 2009-10-23 | 14 |
| K091854 | BIS CLICK SENSOR/CABLE | GXY | 2009-07-02 | 13 |
| K072286 | BIS EEG VISTA MONITOR SYSTEM AND BISX | OLW | 2007-11-20 | 96 |
| K062613 | BIS EEG MONITOR VIEW | OLW | 2007-06-18 | 286 |
| K070069 | ZIPPREP ELECTRODE | GXY | 2007-02-05 | 28 |
| K062692 | BIS BILATERAL SENSOR | GXY | 2006-12-13 | 93 |
| K052981 | BIS EEG MONITOR, MODEL BISX4 | OLW | 2005-11-01 | 8 |
| K052362 | BIS EEG MONITOR, MODEL A-3000 | OLW | 2005-09-09 | 11 |
| K050313 | BIS SRS (SEMI-RESUABLE SENSOR) | GWY | 2005-02-24 | 15 |
| K041670 | BIS PEDIATRIC SENSOR | GXY | 2004-07-06 | 15 |
15 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Aspect Medical Systems, 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.
Frequently asked questions
How many FDA 510(k) clearances does Aspect Medical Systems, Inc. have?
Aspect Medical Systems, Inc. has 25 FDA 510(k) clearances (first 1992, latest 2009), across 5 product codes in 2 review panels.
How long does FDA take to clear Aspect Medical Systems, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Aspect Medical Systems, Inc.'s cleared 510(k)s is 28 days.
What devices does Aspect Medical Systems, Inc. make?
Its most frequent FDA product codes are OLW (Index-Generating Electroencephalograph Software, 12); GXY (Electrode, Cutaneous, 9); OLT (Non-Normalizing Quantitative Electroencephalograph Software, 2).
Has Aspect Medical Systems, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Aspect Medical Systems, Inc. Related entities may recall under other names.
Next steps
- See all 25 Aspect Medical Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OLW, Aspect Medical Systems, 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.