510(k) · Cleared
ClearedMedvision Personal Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medvision, Inc. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Mar 13, 1997 as substantially equivalent to K961800 (Vista Medical Technologies, Inc., 1996) after a 339-day review. Its family tree reaches back 2 generations to 1992. 2 later devices descend from it.
- Decided
- Mar 13, 1997
- Review
- 339 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K923160 (1992). 3 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK923160 3DSCOPEAmerican Surgical Technologies Corp. · 1992
- 1 generation backK961800 Head Mounted DisplayVista Medical Technologies, Inc. · 1996
- This deviceK961343 Medvision Personal MonitorMedvision, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK981999 Albatech Personal MonitorAlbatech, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK990731 Eastgate Personal MonitorEastgate Trading Corp. · 1999
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 |
|---|---|---|---|---|---|
| −2 | K923160 | 3DSCOPE | American Surgical Technologies Corp. | 1992 | — |
| −1 | K961800 | Head Mounted Display | Vista Medical Technologies, Inc. | 1996 | — |
| 0 (this device) | K961343 | Medvision Personal Monitor | Medvision, Inc. | 1997 | — |
| +1 | K981999 | Albatech Personal Monitor | Albatech, Inc. | 1998 | — |
| +1 | K990731 | Eastgate Personal Monitor | Eastgate Trading Corp. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 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 |
|---|---|---|---|
| * | K961800 | Head Mounted Display Cleared while this submission was under review Summary page 1…(908) 422-7745 Predicate Device Trade Name: Head Mounted Display Manufacturer: Vista medical Technologies 5451 Avenida Encinas, Suite A Carlsbad, CA 92008 510 (k)#: K961800 Summary Preparation Date: February 1, 1997 Statement of Intended Use The MedVision Personal Monitor Models A and Models B are i… | 1996 |
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 5 years and passes through 3 companies; a new generation was cleared every 3.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K981999 (Albatech, Inc., 1998) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K961800.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 MedVision Personal Monitor Models A and Models B are intended to display video image while mounted on the user's head.
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/K961343 · printed Nov 4, 2026
Cite this page
510(k) Report. “K961343: Medvision Personal Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K961343
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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