510(k) · Cleared
ClearedAncora-SB
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aspero Medical, Inc. · FDA Enteroscope And Accessories
Cleared on May 1, 2026 as substantially equivalent to K231323 (Aspero Medical, Inc., 2023) after a 91-day review. Its family tree reaches back 8 generations to 2000.
- Decided
- May 1, 2026
- Review
- 91 days
- Class
- Class II
- Product code
- FDA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K993704 (2000). 19 ancestors in all, the oldest K853585 (1986). No later device cites it as a predicate yet.
- Root · 8 generations backK993704 Gastro-Intestinal System EN-410WMFujinon, Inc. · 2000
- 7 generations backK040048 Fujinon Double Balloon Enteroscopy SystemFujinon, Inc. · 2004
- 6 generations backK090116 Fujinon Colonoscope for Double Balloon Enterscopy System Model…Fujinon, Inc. · 2009
- 5 generations backK162428 DiLumen Endolumenal Interventional PlatformLumendi, LLC · 2016
- 4 generations backK173317 DiLumen C2; DiLumen Tool MountLumendi, LLC · 2018
- 3 generations backK211819 DiLumen C2 and Tool MountLumendi, LLC · 2021
- 2 generations backK221452 DiLumen C1, EZ1 and Tool MountLumendi, LLC · 2023
- 1 generation backK231323 Ancora-SBAspero Medical, Inc. · 2023
- This deviceK260314 Ancora-SBAspero Medical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K993704 | Gastro-Intestinal System EN-410WM | Fujinon, Inc. | 2000 | — |
| −7 | K040048 | Fujinon Double Balloon Enteroscopy System | Fujinon, Inc. | 2004 | — |
| −6 | K090116 | Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15 | Fujinon, Inc. | 2009 | — |
| −5 | K162428 | DiLumen Endolumenal Interventional Platform | Lumendi, LLC | 2016 | — |
| −4 | K173317 | DiLumen C2; DiLumen Tool Mount | Lumendi, LLC | 2018 | — |
| −3 | K211819 | DiLumen C2 and Tool Mount | Lumendi, LLC | 2021 | — |
| −2 | K221452 | DiLumen C1, EZ1 and Tool Mount | Lumendi, LLC | 2023 | — |
| −1 | K231323 | Ancora-SB | Aspero Medical, Inc. | 2023 | — |
| 0 (this device) | K260314 | Ancora-SB | Aspero Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 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 FDA? 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 FDA device
- #1 K251204 FUJIFILM Stiffening Wire Device (SW-2000)score 11.0 · 4 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K231323 | Ancora-SBSummary page 5…e Regulation Number: 21CFR 876.1500 Class: II Product Codes: FDA, FED Review Panel: Gastroenterology/Urology 510(k) Number: K231323 Device Description The Ancora-SB is a single-use, close-fitting sleeve that slides freely over a currently marketed standard end… | 2023 |
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 26 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 7 of the 19 ancestors have a recall of any class.
How does its category compare?
All FDA devicesFDA Enteroscope And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · FDA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDA
Too few FDA 510(k)s in any year since 2007 to give a median.
Recalls per year · FDA
No recall names FDA since 2007.
Adverse event reports per year · FDA
116in 2025
MAUDE reports naming product code FDA, 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 | 0 | — | 0 | 1 |
| 2008 | 1 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 28 |
| 2018 | 0 | — | 0 | 81 |
| 2019 | 2 | — | 0 | 76 |
| 2020 | 1 | — | 0 | 29 |
| 2021 | 1 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 87 |
| 2023 | 2 | — | 0 | 72 |
| 2024 | 1 | — | 0 | 86 |
| 2025 | 1 | — | 0 | 116 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Ancora-SB is an accessory to an endoscope. The Ancora-SB is intended for use with any standard endoscope that has an outer diameter of 9.0-9.4 mm and a working length of 1680 mm or greater. The Ancora-SB is intended for use with any standard flexible endoscopy balloon inflation unit with a set pressure of 5.4 kPa (+2.6 kPa, -1.8 kPa). The device is indicated to ensure complete positioning of an endoscope in the small intestine by either oral or anal insertion, and assist with optical visualization, diagnosis, and endoscopic treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K260314 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260314: Ancora-SB.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260314
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026