510(k) · Cleared
ClearedBis SRS (Semi-Resuable Sensor)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aspect Medical Systems, Inc. · GWY Pinwheel
Cleared on Feb 24, 2005 as substantially equivalent to K002734 (Aspect Medical Systems, Inc., 2000) and 1 other predicate after a 15-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Feb 24, 2005
- Review
- 15 days
- Class
- Class I
- Product code
- GWY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K940802 (1994). 2 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K091854Bis Click Sensor/CableAspect Medical Systems, Inc. · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940802 | Zipprep Electrode | Aspect Medical Systems, Inc. | 1994 | — |
| 0 (this device) | K050313 | Bis SRS (Semi-Resuable Sensor) | Aspect Medical Systems, Inc. | 2005 | — |
| +1 | K091854 | Bis Click Sensor/Cable | Aspect Medical Systems, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GWY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K002734 | Aspect Medical Sytems Eeg Enhanced Bis Sensor 186-0106Summary page 1…ystems BIS SRS Common Name: Electrode, Cutaneous Electrode Classification: Class II device. Refer to 21 CFR 882.1320 Predicate Devices: The Aspect Enhanced BIS Sensor, K002734, cleared September 14, 2000 and the Aspect Zipprep Electrode, K940802, cleared June 22, 1994 Device Description: The BIS SRS (S… | 2000 |
| * | K940802 | Zipprep ElectrodeSummary page 1…on: Class II device. Refer to 21 CFR 882.1320 Predicate Devices: The Aspect Enhanced BIS Sensor, K002734, cleared September 14, 2000 and the Aspect Zipprep Electrode, K940802, cleared June 22, 1994 Device Description: The BIS SRS (Semi-reusable sensor) is a single patient use, disposable, pre-gelled 4… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091854 | Bis Click Sensor/Cable | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All GWY devicesGWY Pinwheel: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GWY
FDA has decided no GWY device since 2007.
Median 510(k) review, days · GWY
Too few GWY 510(k)s in any year since 2007 to give a median.
Recalls per year · GWY
No recall names GWY since 2007.
Adverse event reports per year · GWY
No MAUDE report names GWY since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Aspect Medical Systems Semi-Reusable Sensor is applied directly to the patient’s skin to enable recordings of electrophysiological (such as EEG) signals.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K050313 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050313: Bis SRS (Semi-Resuable Sensor).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050313
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026