510(k) · Cleared
ClearedMicrooptical's Critical Data Viewers, Models MD-3 and MD-6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Microoptical Corporation · GCJ Laparoscope, General & Plastic Surgery
Cleared on Mar 24, 2004 as substantially equivalent to K030940 (Microvision Incorporated, 2003) and 1 other predicate after a 50-day review. Its family tree reaches back 3 generations to 1992. 1 later device descends from it.
- Decided
- Mar 24, 2004
- Review
- 50 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K923160 (1992). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK923160 3DSCOPEAmerican Surgical Technologies Corp. · 1992
- 2 generations backK961800 Head Mounted DisplayVista Medical Technologies, Inc. · 1996
- 1 generation backK030940 Nomad ND1000M Augmented Vision SystemMicrovision Incorporated · 2003
- This deviceK040244 Microoptical's Critical Data Viewers, Models MD-3 and MD-6The Microoptical Corporation · 2004
- Descendant · cites it directly · 0 of its ownK042923 MD-6W Wireless Critical Data ViewerThe Microoptical Corporation · 2004
Most influential descendants
Showing 1 of 1 · See all- K042923MD-6W Wireless Critical Data ViewerThe Microoptical Corporation · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K923160 | 3DSCOPE | American Surgical Technologies Corp. | 1992 | — |
| −2 | K961800 | Head Mounted Display | Vista Medical Technologies, Inc. | 1996 | — |
| −1 | K030940 | Nomad ND1000M Augmented Vision System | Microvision Incorporated | 2003 | — |
| 0 (this device) | K040244 | Microoptical's Critical Data Viewers, Models MD-3 and MD-6 | The Microoptical Corporation | 2004 | — |
| +1 | K042923 | MD-6W Wireless Critical Data Viewer | The Microoptical Corporation | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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 |
|---|---|---|---|
| * | K030940 | Nomad ND1000M Augmented Vision SystemSummary page 1…rgery 3. PREDICATE DEVICES MicroOptical's Critical Data Viewers are substantially equivalent to the Nomad ND1000M Augmented Vision System, 510(k) No. K030940 and the Vista Head Mounted Display System (510(k) No. K961800). 4. DEVICE DESCRIPTION MicroOptical's Critical… | 2003 |
| * | K961800 | Head Mounted DisplaySummary page 1…Viewers are substantially equivalent to the Nomad ND1000M Augmented Vision System, 510(k) No. K030940 and the Vista Head Mounted Display System (510(k) No. K961800). 4. DEVICE DESCRIPTION MicroOptical's Critical Data Viewers contain an LCD display unit, non- prescription s… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042923 | MD-6W Wireless Critical Data Viewer | 2004 | 0 |
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 12 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K042923 (The Microoptical Corporation, 2004) has gone furthest, with 0 descendants of its own.
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?
MicroOptical's Critical Data Viewers are intended to display video images or patient data while mounted in front of the user's eye(s) anytime a video display is used. Typical applications include display of images from endoscopic cameras, ultrasound imaging systems, magnetic resonance imaging systems, or display of data from any type of patient monitor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040244 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040244: Microoptical's Critical Data Viewers, Models MD-3 and MD-6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040244
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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