510(k) · Cleared
ClearedSCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Schoelly Fiberoptic GmbH · GCJ Laparoscope, General & Plastic Surgery
Cleared on Jun 20, 2024 as substantially equivalent to K203717 (Fujifilm Corporaton, 2021) and 1 other predicate after a 266-day review. Its family tree reaches back 19 generations to 1994. 3 of the 132 devices in its family, counting itself, have a Class I recall.
- Decided
- Jun 20, 2024
- Review
- 266 days
- Class
- Class II
- Product code
- GCJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 19 generations to K930667 (1994). 131 ancestors in all, the oldest K811390 (1981). No later device cites it as a predicate yet. 3 of the 132 devices in this family, counting this one, have a Class I recall.
- Root · 19 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 15 generations between
- 3 generations backK161792 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016
- 2 generations backK182160 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688…Stryker · 2018 · Recalled
- 1 generation backK221591 Camera System (Camera Control Unit, Camera Head to be coupled to a…Schoelly Fiberoptic GmbH · 2023
- This deviceK233225 SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera…Schoelly Fiberoptic GmbH · 2024
Show all 19 generations
- Root · 19 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
- 18 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
- 17 generations backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
- 16 generations backK021036 Intuitive Surgical DA Vinci Surgical System, Model IS1000Intuitive Surgical, Inc. · 2002 · Recalled
- 15 generations backK040237 Intuitive Surgical DA Vinci Endoscopic Instrument Control System and…Intuitive Surgical, Inc. · 2004
- 14 generations backK043153 Intuitive Surgical DA Vinci Surgical System and Endoscopic…Intuitive Surgical, Inc. · 2004
- 13 generations backK050005 Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip…Intuitive Surgical, Inc. · 2005 · Recalled
- 12 generations backK050404 Intuitive Surgical DA Vinci Surgical System and Endoscopic InstrumentsIntuitive Surgical, Inc. · 2005
- 11 generations backK050802 Modification to Intuitive Surgical DA Vinci Surgical System and…Intuitive Surgical, Inc. · 2005
- 10 generations backK063220 DA Vinci S Surgical System-V1.1, Model IS2000Intuitive Surgical, Inc. · 2006 · Recalled
- 9 generations backK081137 Intuitive Surgical DA Vinci SI Surgical System: Model IS3000Intuitive Surgical, Inc. · 2009 · Recalled
- 8 generations backK090993 Intuitive Surgical Endoscopic Instrument Control Systems, Models…Intuitive Surgical, Inc. · 2009 · Recalled
- 7 generations backK123463 Intuitive Surgical DA Vinci SI Surgical System SmartpedalsIntuitive Surgical, Inc. · 2012 · Recalled
- 6 generations backK131861 DA Vinci Surgical System, Endowrist Instruments and AccessoriesIntuitive Surgical, Inc. · 2014 · Recalled
- 5 generations backK141077 DA Vinci Firefly Imaging SystemIntuitive Surgical, Inc. · 2014 · Recalled
- 4 generations backK150956 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016 · Recalled
- 3 generations backK161792 PINPOINT Endoscopic Fluorescence Imaging SystemNovadaq Technologies, Inc. · 2016
- 2 generations backK182160 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688…Stryker · 2018 · Recalled
- 1 generation backK221591 Camera System (Camera Control Unit, Camera Head to be coupled to a…Schoelly Fiberoptic GmbH · 2023
- This deviceK233225 SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera…Schoelly Fiberoptic GmbH · 2024
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K930667 | Reusable Laparoscopic Instruments | Snowden-Pencer | 1994 | 15 |
| −18 | K960400 | Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line… | Snowden-Pencer | 1996 | — |
| −17 | K990144 | Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic… | Intuitive Surgical, Inc. | 2000 | 3 |
| −16 | K021036 | Intuitive Surgical DA Vinci Surgical System, Model IS1000 | Intuitive Surgical, Inc. | 2002 | 18 |
| −15 | K040237 | Intuitive Surgical DA Vinci Endoscopic Instrument Control System and… | Intuitive Surgical, Inc. | 2004 | — |
| −14 | K043153 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments, Models… | Intuitive Surgical, Inc. | 2004 | — |
| −13 | K050005 | Intuitive Surgical Monopolar Curved Scissors, Model 400179; Tip Cover… | Intuitive Surgical, Inc. | 2005 | 2 |
| −12 | K050404 | Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments | Intuitive Surgical, Inc. | 2005 | — |
| −11 | K050802 | Modification to Intuitive Surgical DA Vinci Surgical System and Endoscopic… | Intuitive Surgical, Inc. | 2005 | — |
| −10 | K063220 | DA Vinci S Surgical System-V1.1, Model IS2000 | Intuitive Surgical, Inc. | 2006 | 4 |
| −9 | K081137 | Intuitive Surgical DA Vinci SI Surgical System: Model IS3000 | Intuitive Surgical, Inc. | 2009 | 25 |
| −8 | K090993 | Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200… | Intuitive Surgical, Inc. | 2009 | 3 |
| −7 | K123463 | Intuitive Surgical DA Vinci SI Surgical System Smartpedals | Intuitive Surgical, Inc. | 2012 | 2 |
| −6 | K131861 | DA Vinci Surgical System, Endowrist Instruments and Accessories | Intuitive Surgical, Inc. | 2014 | 80 |
| −5 | K141077 | DA Vinci Firefly Imaging System | Intuitive Surgical, Inc. | 2014 | 2 |
| −4 | K150956 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies, Inc. | 2016 | 1 |
| −3 | K161792 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies, Inc. | 2016 | — |
| −2 | K182160 | 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K… | Stryker | 2018 | 1 |
| −1 | K221591 | Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic… | Schoelly Fiberoptic GmbH | 2023 | — |
| 0 (this device) | K233225 | SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit… | Schoelly Fiberoptic GmbH | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1991 | 6 | 1 |
| 1992 | 3 | 0 |
| 1993 | 4 | 0 |
| 1994 | 3 | 0 |
| 1995 | 7 | 0 |
| 1996 | 3 | 0 |
| 1997 | 9 | 0 |
| 1998 | 6 | 0 |
| 1999 | 6 | 0 |
| 2000 | 5 | 0 |
| 2001 | 8 | 0 |
| 2002 | 6 | 0 |
| 2003 | 4 | 1 |
| 2004 | 4 | 0 |
| 2005 | 5 | 0 |
| 2006 | 8 | 1 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 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.
3 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K203717 | Processor VP-7000, Light Source BL-7000X, Image Processing Unit EX-0Summary page 6…Unit EX-0 and Light Source BL-7000X serve as the primary predicate device in this submission: 510(k) Sponsor: FUJIFILM Corporation 510(k) Number: K203717 Trade Name Processor VP-7000 and Image Processing Unit EX-0; L… | 2021 |
| * | K221591 | Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)…Summary page 7…. The SCHOELLY NIR FI System serves as the secondary predicate device in this submission: 510(k) Sponsor: Schoelly Fiberoptic GmbH 510(k) Number: K221591 The secondary predicate device is specifically comprised of the flowing components: Trade Name Camer… | 2023 |
| † | K081233 | T-Stat 303 Ischemia Monitoring System | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K061313Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · 6 generations back · ◆ in the 2006 ancestors bar of FIG. 16 Class I recalls
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 7 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 8 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 5 companies; a new generation was cleared every 1.4 years on median.
- 46 of the 131 ancestors have a recall of any class; 3 have a Class I recall.
- 1 other device also cites its predicate K203717.
How does its category compare?
All GCJ devicesGCJ Laparoscope, General & Plastic Surgery: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (consisting of Camera Control Unit and Camera Head) is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process signals transmitted from a fiberoptic endoscope that is connected to the Camera Head. This product may be used on all patients requiring endoscopic examination using SCHOELLY Laparoscopes and FUJIFILM's light source BL-7000X together with…
Read the full statement (160 words)
The SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (consisting of Camera Control Unit and Camera Head) is used for endoscopic observation, diagnosis, treatment, and image recording. It is intended to process signals transmitted from a fiberoptic endoscope that is connected to the Camera Head.
This product may be used on all patients requiring endoscopic examination using SCHOELLY Laparoscopes and FUJIFILM's light source BL-7000X together with monitor, recorder and various peripheral devices. BLI (Blue Light Imaging) and LCI (Linked Color Imaging) are adjunctive tools which can be used to supplement white light endoscopy. BLI and LCI are not intended to replace histopathological sampling as a means of diagnosis.
The SCHOELLY OSI Camera System is further intended for use as an adjunctive monitor of the hemoglobin oxygen saturation of blood in superficial tissue of the endoscopic observation image area in patients at risk for ischemic states. The prospective clinical value of measurements made with OSI has not been demonstrated in disease states.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233225 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233225: SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233225
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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