510(k) · Cleared
ClearedRadiance Ultra Series ZeroWire Embedded
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nds Surgical Imaging, LLC · GCJ Laparoscope, General & Plastic Surgery
Cleared on May 26, 2016 as substantially equivalent to K151609 (Nds Surgical Imaging, LLC, 2015) after a 24-day review. Its family tree reaches back 4 generations to 2008. 2 later devices descend from it.
- Decided
- May 26, 2016
- Review
- 24 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K081995 (2008). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK081995 Stryker Vision Elect Whdtv (Stryker VE Whdtv)Stryker Endoscopy · 2008
- 3 generations backK100195 NDS Surgical Imaging, LLC for the Zerowire Duo Wireless HD Video…Nds Surgical Imaging · 2010
- 2 generations backK112621 WIS1000Foreseeson Custom Displays, Inc. · 2012
- 1 generation backK151609 ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2Nds Surgical Imaging, LLC · 2015
- This deviceK161228 Radiance Ultra Series ZeroWire EmbeddedNds Surgical Imaging, LLC · 2016
- Descendant · cites it directly · 0 of its ownK222890 Radiance Ultra 32 4K Zerowire DuoNds Surgical Imaging, LLC · 2022
- Descendant · cites it directly · 0 of its ownK170598 ZeroWire MobileNds Surgical Imaging, LLC · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K081995 | Stryker Vision Elect Whdtv (Stryker VE Whdtv) | Stryker Endoscopy | 2008 | — |
| −3 | K100195 | NDS Surgical Imaging, LLC for the Zerowire Duo Wireless HD Video Transfer… | Nds Surgical Imaging | 2010 | — |
| −2 | K112621 | WIS1000 | Foreseeson Custom Displays, Inc. | 2012 | — |
| −1 | K151609 | ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2 | Nds Surgical Imaging, LLC | 2015 | — |
| 0 (this device) | K161228 | Radiance Ultra Series ZeroWire Embedded | Nds Surgical Imaging, LLC | 2016 | — |
| +1 | K222890 | Radiance Ultra 32 4K Zerowire Duo | Nds Surgical Imaging, LLC | 2022 | — |
| +1 | K170598 | ZeroWire Mobile | Nds Surgical Imaging, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 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 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 |
|---|---|---|---|
| * | K151609 | ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2Summary page 4…Radiance Ultra series ZeroWire Embedded H. Classification number: 21 CFR 876.1500 I Product Code: GCJ J. Substantial Equivalence: Predicate device K151609 model ZeroWire G2 K. Device Description: Radiance Ultra series ZeroWire Embedded monitors are… | 2015 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 8 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K222890 (Nds Surgical Imaging, LLC, 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K151609.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Radiance Ultra series ZeroWire Embedded and ZeroWire G2 is a paired wireless video communication transmitter and receiver, intended for delivery of video signals from a source such as an endoscopy camera/processor, or other video source over a radio-frequency link to a ZeroWire Receiver for display of images during endoscopic and general surgical procedures. The Radiance Ultra series ZeroWire Embedded and ZeroWire G2 wireless video system is a non-sterile reusable device not intended for use in the sterile field
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161228 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161228: Radiance Ultra Series ZeroWire Embedded.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161228
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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