510(k) · Cleared
ClearedSB Knife Jr2 (MD-47702 and MD-47702L)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sb-Kawasumi Laboratories, Inc. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Mar 26, 2025 as substantially equivalent to K190621 (Sumitomo Bakelite Co., Ltd., 2019) after a 272-day review. Its family tree reaches back 1 generation to 2019.
- Decided
- Mar 26, 2025
- Review
- 272 days
- Class
- Class II
- Product code
- KNS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K190621 (2019). No later device cites it as a predicate yet.
- Root · 1 generation backK190621 SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB…Sumitomo Bakelite Co., Ltd. · 2019
- This deviceK241855 SB Knife Jr2 (MD-47702 and MD-47702L)Sb-Kawasumi Laboratories, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K190621 | SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr… | Sumitomo Bakelite Co., Ltd. | 2019 | — |
| 0 (this device) | K241855 | SB Knife Jr2 (MD-47702 and MD-47702L) | Sb-Kawasumi Laboratories, Inc. | 2025 | — |
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 KNS? 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 KNS device
- #1 K241271 Aqua Medical RF Vapor Ablation Systemscore 17.2 · 20 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 |
|---|---|---|---|
| * | K190621 | SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - LongSummary page 6…Page 2 of 7 e. Predicate devices 510(k): K190621 Trade/Proprietary Name: SB Knife® Common/Usual Name: Endoscopic Electrosurgical Knife Regulation… | 2019 |
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?
- Its one ancestor has no recall.
How does its category compare?
All KNS devicesKNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · KNS
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNS
171in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNS
14in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KNS
1,504in 2025
MAUDE reports naming product code KNS, 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 | 1 | — | 3 | 164 |
| 2008 | 3 | 61 | 5 | 587 |
| 2009 | 3 | 212 | 2 | 1,027 |
| 2010 | 4 | 168 | 0 | 908 |
| 2011 | 1 | — | 2 | 860 |
| 2012 | 2 | — | 0 | 848 |
| 2013 | 2 | — | 0 | 449 |
| 2014 | 1 | — | 0 | 405 |
| 2015 | 3 | 252 | 0 | 406 |
| 2016 | 3 | 30 | 6 | 457 |
| 2017 | 3 | 48 | 1 | 446 |
| 2018 | 5 | 62 | 0 | 563 |
| 2019 | 7 | 66 | 0 | 668 |
| 2020 | 4 | 212 | 0 | 906 |
| 2021 | 4 | 139 | 41 | 814 |
| 2022 | 3 | 182 | 0 | 913 |
| 2023 | 9 | 83 | 0 | 976 |
| 2024 | 3 | 198 | 14 | 1,533 |
| 2025 | 11 | 171 | 0 | 1,504 |
| 2026 | 2 | — | 4 | — |
What is it indicated for?
The SB Knife Jr2 is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47702, MD-47702L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue including Zenker’s diverticulum within the digestive tract using high-frequency current.
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/K241855 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241855: SB Knife Jr2 (MD-47702 and MD-47702L).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241855
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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