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 Aug 31, 2023 as substantially equivalent to K071254 (Olympus Medical Systems Corporation, 2008) and 1 other predicate after a 115-day review. Its family tree reaches back 7 generations to 2000. 1 later device descends from it.
- Decided
- Aug 31, 2023
- Review
- 115 days
- Class
- Class II
- Product code
- FDA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K993704 (2000). 18 ancestors in all, the oldest K853585 (1986). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK993704 Gastro-Intestinal System EN-410WMFujinon, Inc. · 2000
- 6 generations backK040048 Fujinon Double Balloon Enteroscopy SystemFujinon, Inc. · 2004
- 5 generations backK090116 Fujinon Colonoscope for Double Balloon Enterscopy System Model…Fujinon, Inc. · 2009
- 4 generations backK162428 DiLumen Endolumenal Interventional PlatformLumendi, LLC · 2016
- 3 generations backK173317 DiLumen C2; DiLumen Tool MountLumendi, LLC · 2018
- 2 generations backK211819 DiLumen C2 and Tool MountLumendi, LLC · 2021
- 1 generation backK221452 DiLumen C1, EZ1 and Tool MountLumendi, LLC · 2023
- This deviceK231323 Ancora-SBAspero Medical, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK260314 Ancora-SBAspero Medical, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260314Ancora-SBAspero Medical, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K993704 | Gastro-Intestinal System EN-410WM | Fujinon, Inc. | 2000 | — |
| −6 | K040048 | Fujinon Double Balloon Enteroscopy System | Fujinon, Inc. | 2004 | — |
| −5 | K090116 | Fujinon Colonoscope for Double Balloon Enterscopy System Model, EC-450B15 | Fujinon, Inc. | 2009 | — |
| −4 | K162428 | DiLumen Endolumenal Interventional Platform | Lumendi, LLC | 2016 | — |
| −3 | K173317 | DiLumen C2; DiLumen Tool Mount | Lumendi, LLC | 2018 | — |
| −2 | K211819 | DiLumen C2 and Tool Mount | Lumendi, LLC | 2021 | — |
| −1 | K221452 | DiLumen C1, EZ1 and Tool Mount | Lumendi, LLC | 2023 | — |
| 0 (this device) | K231323 | Ancora-SB | Aspero Medical, Inc. | 2023 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 K260314 Ancora-SBscore 13.4 · 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? (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 |
|---|---|---|---|
| * | K071254 | Small Intestinal Videoscope SystemSummary page 4…icate Device Name / Manufacturer Primary Reference Predicate Device K071254 Splinting Tube ST-SB1 (accessory to Small Intestinal… | 2008 |
| * | K221452 | DiLumen C1, EZ1 and Tool MountSummary page 4…to Small Intestinal 9 Videoscope System) / Olympus Medical Systems Corp. K221452 DiLumen C1, EZ1 and Tool Mount / Lumendi, LLC 9 The predicate devices have not been subjec… | 2023 |
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 |
|---|---|---|---|
| K260314 | Ancora-SB | 2026 | 0 |
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 23 years and passes through 3 companies; a new generation was cleared every 3.5 years on median.
- 7 of the 18 ancestors have a recall of any class.
- Of its descendants, K260314 (Aspero Medical, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K071254.
How does its category compare?
All FDA devicesFDA Enteroscope And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K231323 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231323: 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/K231323
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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