510(k) · Cleared
ClearedZerowire Duo Wireless HD Video Transfer System, or Zero Wire
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nds Surgical Imaging · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jun 7, 2013 as substantially equivalent to K100195 (Nds Surgical Imaging, 2010) after a 49-day review. Its family tree reaches back 2 generations to 2008.
- Decided
- Jun 7, 2013
- Review
- 49 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K081995 (2008). No later device cites it as a predicate yet.
- Root · 2 generations backK081995 Stryker Vision Elect Whdtv (Stryker VE Whdtv)Stryker Endoscopy · 2008
- 1 generation backK100195 NDS Surgical Imaging, LLC for the Zerowire Duo Wireless HD Video…Nds Surgical Imaging · 2010
- This deviceK131115 Zerowire Duo Wireless HD Video Transfer System, or Zero WireNds Surgical Imaging · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K081995 | Stryker Vision Elect Whdtv (Stryker VE Whdtv) | Stryker Endoscopy | 2008 | — |
| −1 | K100195 | NDS Surgical Imaging, LLC for the Zerowire Duo Wireless HD Video Transfer… | Nds Surgical Imaging | 2010 | — |
| 0 (this device) | K131115 | Zerowire Duo Wireless HD Video Transfer System, or Zero Wire | Nds Surgical Imaging | 2013 | — |
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 GCJ? 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 GCJ device
- #1 K214046 780 nm 1688 4K Camera System, 780 nm L11 LED…score 21.4 · 21 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 |
|---|---|---|---|
| * | K100195 | NDS Surgical Imaging, LLC for the Zerowire Duo Wireless HD Video Transfer System, Model…Summary page 1…13 Tel: 408-776-0085 Fax: 408-776-9878 Endoscope and Accessories UWB Wireless Device ZeroWire Duo Wireless HD Video Transfer System 21 CFR 876.1500 GCJ. Predicate K100195 ZeroWire Duo Wireless HD Video Transfer System. Model Wu-vwx-yz, where u =R or T; v=P or M; w=1 1o 3; =1to 6; y= 0 to 2; z=1 to… | 2010 |
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 5 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K100195.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · GCJ
21in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GCJ
108in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GCJ
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GCJ
5,860in 2025
MAUDE reports naming product code GCJ, 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 | 18 | 42 | 12 | 1,639 |
| 2008 | 19 | 73 | 16 | 1,319 |
| 2009 | 21 | 85 | 6 | 1,995 |
| 2010 | 24 | 122 | 30 | 2,657 |
| 2011 | 15 | 113 | 9 | 2,133 |
| 2012 | 17 | 88 | 1 | 1,526 |
| 2013 | 15 | 93 | 7 (1) | 1,565 |
| 2014 | 19 | 90 | 2 | 1,714 |
| 2015 | 26 | 76 | 0 | 1,710 |
| 2016 | 27 | 99 | 5 | 2,080 |
| 2017 | 20 | 77 | 1 | 3,468 |
| 2018 | 21 | 88 | 1 | 2,562 |
| 2019 | 15 | 60 | 0 | 2,578 |
| 2020 | 28 | 61 | 0 | 2,618 |
| 2021 | 18 | 116 | 0 | 3,431 |
| 2022 | 20 | 103 | 1 | 3,945 |
| 2023 | 31 | 109 | 1 | 6,002 |
| 2024 | 29 | 90 | 0 | 6,047 |
| 2025 | 21 | 108 | 5 | 5,860 |
| 2026 | 26 | 122 | 1 | — |
What is it indicated for?
The NDSsi ZeroWire Duo Wireless HD Video Transfer System is a paired transmitter and receiver, intended for delivery of video signals over a radio-frequency link to a video display during endoscopic and general surgical procedures. The ZeroWire wireless device is a non-sterile reusable device not intended for use in the sterile field. It is intended for use by quatified physicians having complete knowledge of these surgical procedures.
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/K131115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131115: Zerowire Duo Wireless HD Video Transfer System, or Zero Wire.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131115
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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