510(k) · Cleared
ClearedSIF-SW
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Corp. · FDA Enteroscope And Accessories
Cleared on Mar 27, 1991 after a 154-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 6 later devices descend from it.
- Decided
- Mar 27, 1991
- Review
- 154 days
- Class
- Class II
- Product code
- FDA
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK904800 SIF-SWOlympus Corp. · 1991
- Descendant · cites it directly · 5 of its ownK031256 Xsif-1TQ140A Small Intestinal VideoscopeOlympus Opto-Electronics Co., Ltd. · 2003
- Descendant · 2 generations on · 4 of its ownK051551 Small Intestinal Videoscope SystemOlympus Medical Systems Corporation · 2005
- Descendant · 3 generations on · 3 of its ownK071254 Small Intestinal Videoscope SystemOlympus Medical Systems Corporation · 2008 · Recalled
- Descendant · 4 generations on · 1 of its ownK231323 Ancora-SBAspero Medical, Inc. · 2023
- Descendant · 5 generations on · 0 of its ownK260314 Ancora-SBAspero Medical, Inc. · 2026
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K031256Xsif-1TQ140A Small Intestinal VideoscopeOlympus Opto-Electronics Co., Ltd. · 2003 · cites it directly5descendants
- K051551Small Intestinal Videoscope SystemOlympus Medical Systems Corporation · 2005 · 2 generations on4descendants
- K071254Small Intestinal Videoscope SystemOlympus Medical Systems Corporation · 2008 · 3 generations on3descendants
- K231323Ancora-SBAspero Medical, Inc. · 2023 · 4 generations on1descendant
- K260314Ancora-SBAspero Medical, Inc. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K904800 | SIF-SW | Olympus Corp. | 1991 | — |
| +1 | K031256 | Xsif-1TQ140A Small Intestinal Videoscope | Olympus Opto-Electronics Co., Ltd. | 2003 | — |
| +2 | K051551 | Small Intestinal Videoscope System | Olympus Medical Systems Corporation | 2005 | — |
| +3 | K071254 | Small Intestinal Videoscope System | Olympus Medical Systems Corporation | 2008 | 1 |
| +4 | K231323 | Ancora-SB | Aspero Medical, Inc. | 2023 | — |
| +5 | K260314 | Ancora-SB | Aspero Medical, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031256 | Xsif-1TQ140A Small Intestinal Videoscope | 2003 | 5 |
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?
- Of its descendants, K031256 (Olympus Opto-Electronics Co., Ltd., 2003) has gone furthest, with 5 descendants 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.
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 | — |
https://510kreport.com/device/K904800 · printed Nov 5, 2026
Cite this page
510(k) Report. “K904800: SIF-SW.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K904800
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026