510(k) · Cleared
ClearedLumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 )
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgease Innovations Limited · FAN Sigmoidoscope, Rigid, Electrical
Cleared on Nov 30, 2023 as substantially equivalent to K770291 (Welch Allyn, Inc., 1977) after a 122-day review. Its family tree reaches back 1 generation to 1977.
- Decided
- Nov 30, 2023
- Review
- 122 days
- Class
- Class II
- Product code
- FAN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K770291 (1977). No later device cites it as a predicate yet.
- Root · 1 generation backK770291 Sigmoidoscope, Disposable, Model #53125Welch Allyn, Inc. · 1977
- This deviceK232262 LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables…Surgease Innovations Limited · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K770291 | Sigmoidoscope, Disposable, Model #53125 | Welch Allyn, Inc. | 1977 | — |
| 0 (this device) | K232262 | LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201)… | Surgease Innovations Limited | 2023 | — |
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 FAN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K770291 | Sigmoidoscope, Disposable, Model #53125Summary page 6…Urology Predicate Device: SIGMOIDOSCOPE, DISPOSABLE, MODEL #53125 Manufacturer: Welch Allyn, Inc., United States 510(K) Number: K770291 Reference device: PENTAX Medical VIVIDEO ENT Videoscope Solution, VNL9-CP Manufacturer: Pentax Medica… | 1977 |
| † | K171011 | PENTAX Medical VIVIDEO ENT Videoscope Solution | 2018 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K770291.
How does its category compare?
All FAN devicesFAN Sigmoidoscope, Rigid, Electrical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · FAN
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · FAN
Too few FAN 510(k)s in any year since 2007 to give a median.
Recalls per year · FAN
No recall names FAN since 2007.
Adverse event reports per year · FAN
No MAUDE report names FAN since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The LumenEye® X1 device is intended to be used to examine the rectum, and using additional accessories, perform tissue sampling of the rectum, if required.
The LumenEye® X1 can enable suitably trained healthcare professionals in clinical environments, when used in conjunction with other tests, to examine the rectum as part of a clinical assessment in adults.
The LumenEye® X1 is not intended to determine a final clinical diagnosis without further confirmatory tests. Following examination, the healthcare practitioner may make recommendations for further investigations as appropriate.
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/K232262 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232262: LumenEye® X1 endoscope (LX1-SCP-203); LumenEye® X1 consumables (LX1-CSB-201); LumenEye® X1 Consumable Carton (25 Sets) (LX1-CSP-201 ).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232262
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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