510(k) · Cleared
ClearedView MD Office System, Model 41066.5540
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richard Wolf Medical Instruments Corp. · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jul 19, 2007 as substantially equivalent to K010033 (Richard Wolf Medical Instruments Corp., 2002) and 2 other predicates after a 72-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jul 19, 2007
- Review
- 72 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K950502 (1995). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK950502 CCD Endocam 5501Richard Wolf Medical Instruments Corp. · 1995
- This deviceK071292 View MD Office System, Model 41066.5540Richard Wolf Medical Instruments Corp. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950502 | CCD Endocam 5501 | Richard Wolf Medical Instruments Corp. | 1995 | — |
| 0 (this device) | K071292 | View MD Office System, Model 41066.5540 | Richard Wolf Medical Instruments Corp. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 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? (4)
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 |
|---|---|---|---|
| * | K010033 | Light Projector with Endoscopic Camera, 1 CCD Camera Head NTSC, 1 CCD Camera Head Pal…Summary page 1…ondid vice to whi substantial equivaleneec isclaimed: 510(k) Number Trade or proprietary or model name Manufacturer 1. K010033 1. Light Projector 4251.007 and Endocam Light 1. Richard Wolf 5551.107 with… | 2002 |
| * | K022490 | Ksea Medi PackSummary page 1…007 and Endocam Light 1. Richard Wolf 5551.107 with Camera Heads 5551.961 (NTSC) and 5551.901 (PAL) 2. K022490 2. KSEA Medi Pack 2. Karl Storz 3. Pre-enactment 3. Light source 400… | 2003 |
| * | K950502 | CCD Endocam 5501Summary page 1…Medi Pack 2. Karl Storz 3. Pre-enactment 3. Light source 4008, 4046, 4246 3. Richard Wolf 4. K950502 4. CCD Endocam Office 5501 4. Richard Wolf 2 1.… | 1995 |
| * | — | Light source 4008, 4046, 4246 Named without a submission number |
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?
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K010033.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 "The View MID Office System" is designed to deliver illumination, provide camera use, and display and store medical images obtained during endoscopic surgical or diagnostic procedures
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071292 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071292: View MD Office System, Model 41066.5540.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071292
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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