510(k) · Cleared
ClearedSaneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging (DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging (DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI))
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Saneso, Inc. · FDF Colonoscope And Accessories, Flexible/Rigid
Cleared on Apr 1, 2022 as substantially equivalent to K100584 (Olympus Medical Systems Corporation, 2010) after a 448-day review. Its family tree reaches back 8 generations to 1993. 3 of the 30 devices in its family, counting itself, have a Class I recall. 1 later device descends from it.
- Decided
- Apr 1, 2022
- Review
- 448 days
- Class
- Class II
- Product code
- FDF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K931154 (1993). 28 ancestors in all, the oldest K843084 (1985). 1 later device descends from it, 1 citing it directly. 3 of the 30 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 7 generations backK963033 BF 240/P240/IT240 Bronchovideoscope & AccessoriesOlympus America, Inc. · 1996 · Recalled
- 6 generations backK981543 Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories…The Olympus Optical Co. · 1998 · Recalled
- 5 generations backK013591 Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary…Olympus Optical Co., Ltd. · 2001
- 4 generations backK021073 Visera Rhinlaryngovideoscope Olympus Enf Type VOlympus America, Inc. · 2002
- 3 generations backK031648 Visera Rhino-Laryngovideoscope Olympus Enf Type VOlympus Optical Co., Ltd. · 2003
- 2 generations backK061313 Evis Exera 180 SystemOlympus Medical Systems Corporation · 2006 · Recalled (Class I)
- 1 generation backK100584 Evis Exeraii 180 SystemOlympus Medical Systems Corporation · 2010 · Recalled
- This deviceK210052 Saneso Colonoscope 360-A (Model: with/without Select Band Imaging…Saneso, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK222173 Saneso Lens Wash Bottle Assembly (SAN-LWB-A)Saneso, Inc. · 2023
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K222173Saneso Lens Wash Bottle Assembly (SAN-LWB-A)Saneso, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −7 | K963033 | BF 240/P240/IT240 Bronchovideoscope & Accessories | Olympus America, Inc. | 1996 | 6 |
| −6 | K981543 | Olympus LF-TP and LF-DP Tracheal Intubation Fiberscopes, Accessories and… | The Olympus Optical Co. | 1998 | 5 |
| −5 | K013591 | Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment | Olympus Optical Co., Ltd. | 2001 | — |
| −4 | K021073 | Visera Rhinlaryngovideoscope Olympus Enf Type V | Olympus America, Inc. | 2002 | — |
| −3 | K031648 | Visera Rhino-Laryngovideoscope Olympus Enf Type V | Olympus Optical Co., Ltd. | 2003 | — |
| −2 | K061313 | Evis Exera 180 System | Olympus Medical Systems Corporation | 2006 | Class I |
| −1 | K100584 | Evis Exeraii 180 System | Olympus Medical Systems Corporation | 2010 | 9 |
| 0 (this device) | K210052 | Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and… | Saneso, Inc. | 2022 | — |
| +1 | K222173 | Saneso Lens Wash Bottle Assembly (SAN-LWB-A) | Saneso, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1991 | 2 | 1 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 1 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 FDF device
- #1 K230332 Ambu® aScope™ Colon; Ambu® aBox™ 2score 20.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222173 | Saneso Lens Wash Bottle Assembly (SAN-LWB-A) | 2023 | 0 |
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 · 2 generations back · ◆ on the line of descent in FIG. 16 Class I recalls
- K023984Modification to Olympus Bronchoscopes BF-40 Series, BF-240 Series, and BF-160 SeriesThe Olympus Optical Co. · 2003 · 3 generations back · ◆ in the 2003 ancestors bar of FIG. 114 Class I recalls
- K912120Urf-P2 Ureterorenofiberscope/CholedochofiberscopeOlympus Corp. · 1991 · 4 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 3.1 years on median.
- 16 of the 28 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K222173 (Saneso, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 21 other devices also cite its predicate K100584.
How does its category compare?
All FDF devicesFDF Colonoscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · FDF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDF
194in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDF
8in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDF
17,231in 2025
MAUDE reports naming product code FDF, 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 | 4 | 70 | 0 | 81 |
| 2008 | 2 | — | 0 | 68 |
| 2009 | 6 | 91 | 0 | 83 |
| 2010 | 4 | 101 | 0 | 48 |
| 2011 | 2 | — | 0 | 77 |
| 2012 | 7 | 241 | 0 | 88 |
| 2013 | 2 | — | 0 | 63 |
| 2014 | 6 | 164 | 0 | 60 |
| 2015 | 2 | — | 1 | 100 |
| 2016 | 7 | 98 | 1 | 170 |
| 2017 | 4 | 36 | 0 | 370 |
| 2018 | 7 | 101 | 0 | 388 |
| 2019 | 4 | 56 | 0 | 417 |
| 2020 | 4 | 250 | 1 | 687 |
| 2021 | 3 | 30 | 0 | 2,444 |
| 2022 | 5 | 147 | 0 | 8,345 |
| 2023 | 6 | 203 | 8 | 11,748 |
| 2024 | 2 | — | 0 | 12,128 |
| 2025 | 4 | 194 | 0 | 17,231 |
| 2026 | 5 | 147 | 0 | — |
What is it indicated for?
The Saneso Colonoscope 360-A is intended for diagnostic visualization of the lower gastrointestinal tract (including the rectum, colon and cecum) and Saneso Colonoscope 360-A is not indicated for ileoscopy procedures. The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consists of Saneso Colonoscope 360-A, Saneso Processor-A and other ancillary equipment. The Saneso Gastroscope 360-A is intended…
Read the full statement (206 words)
The Saneso Colonoscope 360-A is intended for diagnostic visualization of the lower gastrointestinal tract (including the rectum, colon and cecum) and Saneso Colonoscope 360-A is not indicated for ileoscopy procedures. The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consists of Saneso Colonoscope 360-A, Saneso Processor-A and other ancillary equipment.
The Saneso Gastroscope 360-A is intended for diagnostic visualization of the upper gastrointestinal tract (including the esophagus, stomach and duodenum). The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consists of Saneso Gastroscope 360-A/Saneso Single Camera Gastroscope-A, Saneso Processor-A and other ancillary equipment.
The Saneso Single Camera Colonoscope-A is intended for diagnostic visualization of the lower gastrointestinal tract (including the rectum, colon and ileocecal valve). The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consists of Saneso Colonoscope 360-A/Saneso Single Camera Colonoscope-A, Saneso Processor-A and other ancillary equipment.
The Saneso Single Camera Gastroscope-A is intended for diagnostic visualization of the upper gastrointestinal tract (including the esophagus, stomach and duodenum). The system also provides access for therapeutic interventions using standard endoscopy tools. The Saneso system consists of Saneso Gastroscope 360-A/Saneso Single Camera Gastroscope-A, Saneso Processor-A and other ancillary equipment.
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/K210052 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210052: Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging (DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging (DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI)).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210052
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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