Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Aspect Medical Systems, Inc. · Predicate Candidate Screening
25 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
242 days90th percentile
25clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093183 | BIS QUATRO SENSOR | Aspect Medical Systems, Inc. | 2009-10-23 | 14 | 0 |
| K091854 | BIS CLICK SENSOR/CABLE | Aspect Medical Systems, Inc. | 2009-07-02 | 13 | 0 |
| K072286 | BIS EEG VISTA MONITOR SYSTEM AND BISX | Aspect Medical Systems, Inc. | 2007-11-20 | 96 | 0 |
| K062613 | BIS EEG MONITOR VIEW | Aspect Medical Systems, Inc. | 2007-06-18 | 286 | 0 |
| K070069 | ZIPPREP ELECTRODE | Aspect Medical Systems, Inc. | 2007-02-05 | 28 | 0 |
| K062692 | BIS BILATERAL SENSOR | Aspect Medical Systems, Inc. | 2006-12-13 | 93 | 1 |
| K052981 | BIS EEG MONITOR, MODEL BISX4 | Aspect Medical Systems, Inc. | 2005-11-01 | 8 | 0 |
| K052362 | BIS EEG MONITOR, MODEL A-3000 | Aspect Medical Systems, Inc. | 2005-09-09 | 11 | 0 |
| K050313 | BIS SRS (SEMI-RESUABLE SENSOR) | Aspect Medical Systems, Inc. | 2005-02-24 | 15 | 0 |
| K041670 | BIS PEDIATRIC SENSOR | Aspect Medical Systems, Inc. | 2004-07-06 | 15 | 0 |
| K040183 | BISX | Aspect Medical Systems, Inc. | 2004-02-25 | 29 | 0 |
| K030267 | EEG MONITOR WITH BIS, MODEL A-2000 | Aspect Medical Systems, Inc. | 2004-01-15 | 353 | 0 |
| K031694 | MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000 | Aspect Medical Systems, Inc. | 2003-08-29 | 88 | 0 |
| K011834 | BIS ENGINE | Aspect Medical Systems, Inc. | 2001-07-10 | 28 | 0 |
| K011534 | EEG MIS MONITOR MODEL # A-2000; BIS ENGINE | Aspect Medical Systems, Inc. | 2001-06-15 | 28 | 0 |
| K001980 | ASPECT MEDICAL SYSTEMS PEDIATRIC BIS EEG SENSOR, MODEL 186-0 | Aspect Medical Systems, Inc. | 2000-09-27 | 90 | 0 |
| K002837 | BIS ENGINE | Aspect Medical Systems, Inc. | 2000-09-19 | 7 | 0 |
| K002734 | ASPECT MEDICAL SYTEMS EEG ENHANCED BIS SENSOR 186-0106 | Aspect Medical Systems, Inc. | 2000-09-14 | 13 | 0 |
| K994330 | ASPECT MEDICAL SYSTEMS EEG SENSOR, MODEL 186-0076 | Aspect Medical Systems, Inc. | 2000-01-18 | 26 | 0 |
| K974496 | A-2000 EEG MONITOR WITH BIS | Aspect Medical Systems, Inc. | 1998-02-06 | 70 | 0 |
| K963644 | A-1000 EEG MONITOR AND A-1050 EEG MONITOR | Aspect Medical Systems, Inc. | 1996-10-08 | 26 | 0 |
| K961821 | ASPECT MEDICAL SYSTEMS ZIPPREP EEG SENSOR | Aspect Medical Systems, Inc. | 1996-10-04 | 147 | 0 |
| K952347 | A-1050 EEG MONITOR | Aspect Medical Systems, Inc. | 1996-01-16 | 242 | 0 |
| K940802 | ZIPPREP ELECTRODE | Aspect Medical Systems, Inc. | 1994-06-22 | 120 | 0 |
| K923043 | SPECTRAL EEG MONITOR MODEL A1000 | Aspect Medical Systems, Inc. | 1992-12-03 | 162 | 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