510(k) · Cleared
ClearedSB Soft Hood - Straight type, SB Soft Hood - Undercut type
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sumitomo Bakelite Co., Ltd. · FDS Gastroscope And Accessories, Flexible/Rigid
Cleared on May 8, 2018 as substantially equivalent to K984358 (Olympus America, Inc., 1999) after a 223-day review. Its family tree reaches back 3 generations to 1986.
- Decided
- May 8, 2018
- Review
- 223 days
- Class
- Class II
- Product code
- FDS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K853585 (1986). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK853585 Olympus Evs-Endoscopic Video Image & Data SysOlympus Corp. · 1986 · Recalled
- 2 generations backK954451 Evis 140 SystemOlympus America, Inc. · 1996 · Recalled
- 1 generation backK984358 Olympus Distal Attachment, Models…Olympus America, Inc. · 1999 · Recalled
- This deviceK173004 SB Soft Hood - Straight type, SB Soft Hood - Undercut typeSumitomo Bakelite Co., Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K853585 | Olympus Evs-Endoscopic Video Image & Data Sys | Olympus Corp. | 1986 | 2 |
| −2 | K954451 | Evis 140 System | Olympus America, Inc. | 1996 | 3 |
| −1 | K984358 | Olympus Distal Attachment, Models… | Olympus America, Inc. | 1999 | 2 |
| 0 (this device) | K173004 | SB Soft Hood - Straight type, SB Soft Hood - Undercut type | Sumitomo Bakelite Co., Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 FDS? 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 FDS device
- #1 K251708 EvoEndo Single-Use Endoscopy Systemscore 16.5 · 12 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 |
|---|---|---|---|
| * | K984358 | Olympus Distal Attachment, Models…Summary page 4…s Product Code: FDS Device Class: II 4. Predicate Devices Olympus Optical Corporation: Olympus Distal Attachment (K984358) 5. Device Description SB Soft Hood™ is a transparent distal attachment applied to the tip of an endoscope.… | 1999 |
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 32 years and passes through 3 companies; a new generation was cleared every 10.2 years on median.
- 3 of the 4 ancestors have a recall of any class.
- 6 other devices also cite its predicate K984358.
How does its category compare?
All FDS devicesFDS Gastroscope And Accessories, Flexible/Rigid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · FDS
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FDS
211in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FDS
2in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FDS
18,905in 2025
MAUDE reports naming product code FDS, 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 | 2 | — | 0 | 27 |
| 2008 | 0 | — | 0 | 11 |
| 2009 | 0 | — | 0 | 21 |
| 2010 | 1 | — | 0 | 45 |
| 2011 | 1 | — | 0 | 36 |
| 2012 | 3 | 181 | 0 | 35 |
| 2013 | 2 | — | 1 | 8 |
| 2014 | 2 | — | 0 | 23 |
| 2015 | 2 | — | 0 | 29 |
| 2016 | 1 | — | 1 | 108 |
| 2017 | 1 | — | 0 | 178 |
| 2018 | 6 | 167 | 0 | 304 |
| 2019 | 5 | 175 | 0 | 1,376 |
| 2020 | 2 | — | 2 | 601 |
| 2021 | 5 | 78 | 0 | 1,755 |
| 2022 | 2 | — | 0 | 6,216 |
| 2023 | 3 | 133 | 0 | 9,874 |
| 2024 | 5 | 220 | 2 | 9,258 |
| 2025 | 8 | 211 | 0 | 18,905 |
| 2026 | 7 | 164 | 0 | — |
What is it indicated for?
SB Soft Hood is intended for use with SB Knife for endoscopic submucosal dissection within the gastrointestinal tract and
for use in keeping the suitable depth of endoscopic field of view.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173004: SB Soft Hood - Straight type, SB Soft Hood - Undercut type.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173004
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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