510(k) · Cleared
ClearedBioWave BioWraps
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biowave Corporation · GXY Electrode, Cutaneous
Cleared on Jun 3, 2026 as substantially equivalent to K203158 (Biowave Corporation, 2021) after a 27-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Jun 3, 2026
- Review
- 27 days
- Class
- Class II
- Product code
- GXY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K932299 (1994). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK932299 Electro-MeshPrizm Medical, Inc. · 1994
- 4 generations backK053214 Theraknit Garment ElectrodeNeurotron Medical · 2005
- 3 generations backK171721 Electrodes with silver conductiveShenzhen Konmed Technology Co., Ltd. · 2018
- 2 generations backK171798 Silverwear Silver Pro Garment DeviceMedia Plus, LLC · 2018
- 1 generation backK203158 BioWave BioWrapsBiowave Corporation · 2021
- This deviceK261522 BioWave BioWrapsBiowave Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K932299 | Electro-Mesh | Prizm Medical, Inc. | 1994 | — |
| −4 | K053214 | Theraknit Garment Electrode | Neurotron Medical | 2005 | — |
| −3 | K171721 | Electrodes with silver conductive | Shenzhen Konmed Technology Co., Ltd. | 2018 | — |
| −2 | K171798 | Silverwear Silver Pro Garment Device | Media Plus, LLC | 2018 | — |
| −1 | K203158 | BioWave BioWraps | Biowave Corporation | 2021 | — |
| 0 (this device) | K261522 | BioWave BioWraps | Biowave Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 0 |
| 2014 | 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 GXY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GXY device
- #1 K232052 Ceribell Instant EEG Headbandscore 16.3 · 6 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K203158 | BioWave BioWrapsSummary page 6…rostimulators. Predicate Device: The BioWave Corporation’s BioWave BioWraps are substantially equivalent to the primary predicate (BioWave BioWraps - K203158) previously cleared with respect to indications, design, function, and materials, as outlined below. Performance Tes… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 32 years and passes through 5 companies; a new generation was cleared every 4.9 years on median.
- None of the 8 ancestors has a recall.
- 1 other device also cites its predicate K203158.
How does its category compare?
All GXY devicesGXY Electrode, Cutaneous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · GXY
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GXY
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GXY
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GXY
58in 2025
MAUDE reports naming product code GXY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 7 | 88 | 0 | 14 |
| 2008 | 9 | 136 | 0 | 17 |
| 2009 | 17 | 159 | 4 | 15 |
| 2010 | 3 | 137 | 1 | 14 |
| 2011 | 6 | 183 | 5 | 16 |
| 2012 | 9 | 150 | 4 | 16 |
| 2013 | 7 | 99 | 0 | 15 |
| 2014 | 9 | 203 | 0 | 11 |
| 2015 | 6 | 119 | 0 | 19 |
| 2016 | 6 | 170 | 0 | 15 |
| 2017 | 9 | 116 | 0 | 11 |
| 2018 | 14 | 135 | 0 | 10 |
| 2019 | 9 | 113 | 0 | 19 |
| 2020 | 4 | 108 | 0 | 11 |
| 2021 | 12 | 195 | 0 | 21 |
| 2022 | 5 | 81 | 0 | 34 |
| 2023 | 13 | 132 | 2 | 25 |
| 2024 | 7 | 111 | 0 | 51 |
| 2025 | 6 | 148 | 0 | 58 |
| 2026 | 12 | 70 | 0 | — |
What is it indicated for?
The BioWave BioWraps are cutaneous electrodes to be used with legally marketed BioWave branded neurostimulators. The knitted garment electrodes are non-sterile reusable prescription-use conductive garments that are intended to deliver the stimulation signals generated by the stimulator to the body surface with which they are in contact. These body parts can include hand/wrist, elbow, foot/ankle, knee, thigh/calf, cervical neck and lower back.
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/K261522 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261522: BioWave BioWraps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261522
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026