510(k) · Cleared
Recalled · Class II · 2023Small Intestinal Videoscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corporation · FDA Enteroscope And Accessories
Cleared on Mar 25, 2008 as substantially equivalent to K051551 (Olympus Medical Systems Corporation, 2005) after a 326-day review. Its family tree reaches back 4 generations to 1986. 3 later devices descend from it. It has been recalled once.
- Decided
- Mar 25, 2008
- Review
- 326 days
- Class
- Class II
- Product code
- FDA
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K853585 (1986). 9 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 3 generations backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- 2 generations backK031256 Xsif-1TQ140A Small Intestinal VideoscopeOlympus Opto-Electronics Co., Ltd. · 2003
- 1 generation backK051551 Small Intestinal Videoscope SystemOlympus Medical Systems Corporation · 2005
- This deviceK071254 Small Intestinal Videoscope SystemOlympus Medical Systems Corporation · 2008
- Descendant · cites it directly · 1 of its ownK231323 Ancora-SBAspero Medical, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK260314 Ancora-SBAspero Medical, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK091759 Single Use Splinting Tube, Models ST-Y0002-S, ST-Y0002-H, ST-Y0003-S…Olympus Medical Systems Corporation · 2009
Most influential descendants
Showing 3 of 3 · See all- K231323Ancora-SBAspero Medical, Inc. · 2023 · cites it directly1descendant
- K260314Ancora-SBAspero Medical, Inc. · 2026 · 2 generations on0descendants
- K091759Single Use Splinting Tube, Models ST-Y0002-S, ST-Y0002-H, ST-Y0003-S and ST-Y0003-HOlympus Medical Systems Corporation · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −3 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| −2 | K031256 | Xsif-1TQ140A Small Intestinal Videoscope | Olympus Opto-Electronics Co., Ltd. | 2003 | — |
| −1 | K051551 | Small Intestinal Videoscope System | Olympus Medical Systems Corporation | 2005 | — |
| 0 (this device) | K071254 | Small Intestinal Videoscope System | Olympus Medical Systems Corporation | 2008 | — |
| +1 | K231323 | Ancora-SB | Aspero Medical, Inc. | 2023 | — |
| +2 | K260314 | Ancora-SB | Aspero Medical, Inc. | 2026 | — |
| +1 | K091759 | Single Use Splinting Tube, Models ST-Y0002-S, ST-Y0002-H, ST-Y0003-S and… | Olympus Medical Systems Corporation | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 2000 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2023 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K051551 | Small Intestinal Videoscope SystemSummary page 2…3. Predicate Device Information Model 510(k) # Manufacturer Class Product Code Small Intestinal Videoscope K051551 Olympus Medical Systems Corp. FDA & KNT System 4. Device Description The subject device, Small Intestinal… | 2005 |
| † | K051645 | Evis Exera 160A System | 2005 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 25, 2023 | Class II | Z-0343-2024 | Under Investigation by firm | Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K231323 (Aspero Medical, Inc., 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All FDA devicesFDA Enteroscope And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
SMALL INTESTINAL VIDEOSCOPE SYSTEM This system is composed of the small intestinal videoscope and the other ancillary equipment. The small intestinal scope has been designed to be used with an Olympus video system center, light source, balloon control unit, splinting tube, documentation equipment, video monitor, electrosurgical unit, endo-therapy accessories such as biopsy forceps and other ancillary equipment for endoscopic diagnosis and endoscopic…
Read the full statement (202 words)
SMALL INTESTINAL VIDEOSCOPE SYSTEM
This system is composed of the small intestinal videoscope and the other ancillary equipment. The small intestinal scope has been designed to be used with an Olympus video system center, light source, balloon control unit, splinting tube, documentation equipment, video monitor, electrosurgical unit, endo-therapy accessories such as biopsy forceps and other ancillary equipment for endoscopic diagnosis and endoscopic surgery within the upper and lower digestive tract including the esophagus, stomach, duodenum, small intestine and colon, by either oral anal insertion.
Indications for Use of the Components are as follows:
SIF-Q180 SMALL INTESTINAL VIDEOSCOPE
This instrument has been designed to be used with an Olympus video system center, light source, single use splinting tube, balloon control unit, documentation equipment, video monitor, endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within the upper and lower digestive tract (including the esophagus, stomach, duodenum colon, and small intestine) by either oral and anal insertion.
OBCU Balloon Control Unit
This balloon control unit has been designed for inflating and deflating the balloon attached to the distal end of a single use splinting tube in order to assist the insertion of an Olympus-designated small intestinal endoscope.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071254 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071254: Small Intestinal Videoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071254
Report an extraction error
Are you the manufacturer?
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