510(k) · Cleared
ClearedWIS1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Foreseeson Custom Displays, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on May 30, 2012 as substantially equivalent to K081995 (Stryker Endoscopy, 2008) and 1 other predicate after a 265-day review. Its family tree reaches back 2 generations to 2008. 4 later devices descend from it.
- Decided
- May 30, 2012
- Review
- 265 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K081995 (2008). 4 later devices descend from it, 1 citing it directly.
- 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 deviceK112621 WIS1000Foreseeson Custom Displays, Inc. · 2012
- Descendant · cites it directly · 3 of its ownK151609 ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2Nds Surgical Imaging, LLC · 2015
- Descendant · 2 generations on · 2 of its ownK161228 Radiance Ultra Series ZeroWire EmbeddedNds Surgical Imaging, LLC · 2016
- Descendant · 2 generations on · 0 of its ownK222890 Radiance Ultra 32 4K Zerowire DuoNds Surgical Imaging, LLC · 2022
- Descendant · 2 generations on · 0 of its ownK170598 ZeroWire MobileNds Surgical Imaging, LLC · 2017
Most influential descendants
Showing 4 of 4 · See all- K151609ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2Nds Surgical Imaging, LLC · 2015 · cites it directly3descendants
- K161228Radiance Ultra Series ZeroWire EmbeddedNds Surgical Imaging, LLC · 2016 · 2 generations on2descendants
- K222890Radiance Ultra 32 4K Zerowire DuoNds Surgical Imaging, LLC · 2022 · 2 generations on0descendants
- K170598ZeroWire MobileNds Surgical Imaging, LLC · 2017 · 2 generations on0descendants
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) | 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 | — |
| +2 | K161228 | Radiance Ultra Series ZeroWire Embedded | Nds Surgical Imaging, LLC | 2016 | — |
| +2 | K222890 | Radiance Ultra 32 4K Zerowire Duo | Nds Surgical Imaging, LLC | 2022 | — |
| +2 | K170598 | ZeroWire Mobile | Nds Surgical Imaging, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K081995 | Stryker Vision Elect Whdtv (Stryker VE Whdtv)Summary page 1…urer: Stryker Predicate Device Common Name: Endoscope and accessories. *Predicate Device Premarket Notification # K08 1995 Predicate Device Classification: 21 CFR 876.1500 Predicate Device Classification & Class… | 2008 |
| * | K100195 | NDS Surgical Imaging, LLC for the Zerowire Duo Wireless HD Video Transfer System, Model…Summary page 1…turer: NDSsi Predicate Device Common Name: Endoscope and accessories. Predicate Device Premarket Notification # K100195 Predicate Device Classification: 21 CFR 876.1500 Predicate Device Classification & Class… | 2010 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151609 | ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2 | 2015 | 3 |
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 4 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K151609 (Nds Surgical Imaging, LLC, 2015) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K081995.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 Foreseeson Custom Display's WIS1000 transmitter and receiver wirelessly transmit (60GHz) high quality audio and video (up to 1080p/60Hz) to displays during endoscopic and surgical procedures including arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery), thorascopy, endoscopy (general, gastroenterological and ENT surgery) and general surgery. The WIS1000 wireless components are non-sterile reusable devices not intended for use in the sterile field.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112621 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112621: WIS1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112621
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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