510(k) · Cleared
ClearedLight Projector with Endoscopic Camera, 1 CCD Camera Head NTSC, 1 CCD Camera Head Pal, Light Projector, Model 5551.107
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 Jan 10, 2002 after a 371-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 12 later devices descend from it.
- Decided
- Jan 10, 2002
- Review
- 371 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 2 citing it directly.
- This deviceK010033 Light Projector with Endoscopic Camera, 1 CCD Camera Head NTSC, 1…Richard Wolf Medical Instruments Corp. · 2002
- Descendant · cites it directly · 10 of its ownK072912 Sopro 225 Dual Halogen Light SourceSopro · 2007
- Descendant · 2 generations on · 9 of its ownK091829 PLS Portable Light SourceOptim, Inc. · 2009
- Descendant · 3 generations on · 6 of its ownK130503 Pathassist Led Light FiberEntellus Medical, Inc. · 2013
- Descendant · 4 generations on · 5 of its ownK141916 Pathassist Led Light FiberEntellus Medical, Inc. · 2014
- Descendant · 5 generations on · 2 of its ownK152435 PassAssist LED Light FiberEntellus Medical, Inc. · 2015
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K072912Sopro 225 Dual Halogen Light SourceSopro · 2007 · cites it directly10descendants
- K091829PLS Portable Light SourceOptim, Inc. · 2009 · 2 generations on9descendants
- K130503Pathassist Led Light FiberEntellus Medical, Inc. · 2013 · 3 generations on6descendants
- K141916Pathassist Led Light FiberEntellus Medical, Inc. · 2014 · 4 generations on5descendants
- K152435PassAssist LED Light FiberEntellus Medical, Inc. · 2015 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010033 | Light Projector with Endoscopic Camera, 1 CCD Camera Head NTSC, 1 CCD Camera… | Richard Wolf Medical Instruments Corp. | 2002 | — |
| +1 | K072912 | Sopro 225 Dual Halogen Light Source | Sopro | 2007 | — |
| +2 | K091829 | PLS Portable Light Source | Optim, Inc. | 2009 | — |
| +3 | K130503 | Pathassist Led Light Fiber | Entellus Medical, Inc. | 2013 | — |
| +4 | K141916 | Pathassist Led Light Fiber | Entellus Medical, Inc. | 2014 | — |
| +5 | K152435 | PassAssist LED Light Fiber | Entellus Medical, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (12)
See all 122 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?
- Of its descendants, K072912 (Sopro, 2007) has gone furthest, with 10 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 | — |
https://510kreport.com/device/K010033 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010033: Light Projector with Endoscopic Camera, 1 CCD Camera Head NTSC, 1 CCD Camera Head Pal, Light Projector, Model 5551.107.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010033
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026