510(k) · Cleared
ClearedEastgate Personal Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eastgate Trading Corp. · GCJ Laparoscope, General & Plastic Surgery
Cleared on May 19, 1999 as substantially equivalent to K981999 (Albatech, Inc., 1998) and 1 other predicate after a 75-day review. Its family tree reaches back 4 generations to 1992.
- Decided
- May 19, 1999
- Review
- 75 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K923160 (1992). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK923160 3DSCOPEAmerican Surgical Technologies Corp. · 1992
- 3 generations backK961800 Head Mounted DisplayVista Medical Technologies, Inc. · 1996
- 2 generations backK961343 Medvision Personal MonitorMedvision, Inc. · 1997
- 1 generation backK981999 Albatech Personal MonitorAlbatech, Inc. · 1998
- This deviceK990731 Eastgate Personal MonitorEastgate Trading Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K923160 | 3DSCOPE | American Surgical Technologies Corp. | 1992 | — |
| −3 | K961800 | Head Mounted Display | Vista Medical Technologies, Inc. | 1996 | — |
| −2 | K961343 | Medvision Personal Monitor | Medvision, Inc. | 1997 | — |
| −1 | K981999 | Albatech Personal Monitor | Albatech, Inc. | 1998 | — |
| 0 (this device) | K990731 | Eastgate Personal Monitor | Eastgate Trading Corp. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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.
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 7 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- None of the 5 ancestors has a recall.
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?
'E EASTGATE TRADING PERSONAL MONITOR CAN BE USED FOR ANY PROCEDURE _.HAT REQUIRES A VIDEO DISPLAY.IT IS DESIGNED TO SIT ON THE BRIDGE OF THE NOSE.IN THIS POSITION A MEDICAL PERSON ABLE TO SEE THE MONITOR PICTURE AND THE SURROUNDING AREA AT THE SAME TIME. THE PERSONAL MONITOR IS PROVIDED WITH ACCESSORIES TO PLUG INTO ANY VIDEO OUTPUT.IT CAN BE USED BY ITSELF OR IN CONJUNCTION WITH OTHER VIDEO MONITORS. AS AN EXAMPLE IN ENDOSCOPIC SURGERY THE DOCTOR WOULD…
Read the full statement (124 words)
'E EASTGATE TRADING PERSONAL MONITOR CAN BE USED FOR ANY PROCEDURE _.HAT REQUIRES A VIDEO DISPLAY.IT IS DESIGNED TO SIT ON THE BRIDGE OF THE NOSE.IN THIS POSITION A MEDICAL PERSON ABLE TO SEE THE MONITOR PICTURE AND THE SURROUNDING AREA AT THE SAME TIME.
THE PERSONAL MONITOR IS PROVIDED WITH ACCESSORIES TO PLUG INTO ANY VIDEO OUTPUT.IT CAN BE USED BY ITSELF OR IN CONJUNCTION WITH OTHER VIDEO MONITORS.
AS AN EXAMPLE IN ENDOSCOPIC SURGERY THE DOCTOR WOULD ATTACH THE VIDEO FEED TO THE REGULAR MONITOR DEVICE.BY DOING THIS THE DOCTOR COULD VIEW THE PATIENT AND THE CAMERA IMAGE AT THE SAME TIME.
AS THIS MONITOR HAS A UNIVERSAL VIDEO PLUG IT COULD BE ATTACHED TO ANY MEDICAL DEVICE WITH A VIDEO OUTPUT.
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/K990731 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990731: Eastgate Personal Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990731
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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