510(k) · Cleared
ClearedSleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Haemoband Surgical, Ltd. · FER Anoscope And Accessories
Cleared on Oct 9, 2025 as substantially equivalent to K070913 (Sapimed S.P.A., 2007) after a 219-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Oct 9, 2025
- Review
- 219 days
- Class
- Class II
- Product code
- FER
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K993738 (2000). 5 ancestors in all, the oldest K810227 (1981). No later device cites it as a predicate yet.
- Root · 3 generations backK993738 Dispos-a-ScopeDispos-A-Scope · 2000
- 2 generations backK020702 O'regan Disposable AnoscopeCanadian Theatre Products, Ltd. · 2002
- 1 generation backK070913 Self-Light Disposable AnoscopeSapimed S.P.A. · 2007 · Recalled
- This deviceK250645 SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16…Haemoband Surgical, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K993738 | Dispos-a-Scope | Dispos-A-Scope | 2000 | — |
| −2 | K020702 | O'regan Disposable Anoscope | Canadian Theatre Products, Ltd. | 2002 | — |
| −1 | K070913 | Self-Light Disposable Anoscope | Sapimed S.P.A. | 2007 | 1 |
| 0 (this device) | K250645 | SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope… | Haemoband Surgical, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1996 | 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 FER? 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 FER device
- #1 K230439 WellCare Anoscopescore 8.3 · 7 generations · no Class I recall
- #2 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K070913 | Self-Light Disposable AnoscopeSummary page 5…1500 Product Code(s) FER, GCP I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K070913 Self-light disposable anoscope/proctoscope FER Device Description Summary 21 CFR 807.92(a)(4) The SleeveLUX Anoscope/Proctoscope… | 2007 |
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?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 5 ancestors has a recall of any class.
- 4 other devices also cite its predicate K070913.
How does its category compare?
All FER devicesFER Anoscope And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · FER
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FER
Too few FER 510(k)s in any year since 2007 to give a median.
Recalls per year · FER
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FER
3in 2025
MAUDE reports naming product code FER, 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 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 1 |
| 2013 | 1 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 14 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 0 | — | 1 | 4 |
| 2019 | 0 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 18 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 1 | — | 0 | 6 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
SleeveLUX Anoscope/Proctoscope is a class 2 self-illuminating disposable instrument used to assist clinicians when treating and/or diagnose conditions in the anal canal and the lower rectum such as
1st 2nd and 3rd degree hemorrhoids.
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/K250645 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250645: SleeveLUX 24 Anoscope/Proctoscope (P2001); SleeveLUX 16 Anoscope/Proctoscope (P2002).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250645
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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