510(k) · Cleared
Recalled · Class II · 2016SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sumitomo Bakelite Co., Ltd. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Jun 17, 2016 as substantially equivalent to K092309 (Olympus Medical Systems Corporation, 2009) after a 266-day review. Its family tree reaches back 1 generation to 2009. It has been recalled 2 times.
- Decided
- Jun 17, 2016
- Review
- 266 days
- Class
- Class II
- Product code
- KNS
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K092309 (2009). No later device cites it as a predicate yet.
- Root · 1 generation backK092309 Single Use Electrosurgical Knife Series, Model KD-610L, KD-611L…Olympus Medical Systems Corporation · 2009 · Recalled
- This deviceK152771 SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB…Sumitomo Bakelite Co., Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K092309 | Single Use Electrosurgical Knife Series, Model KD-610L, KD-611L, KD-620LR… | Olympus Medical Systems Corporation | 2009 | 9 |
| 0 (this device) | K152771 | SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr… | Sumitomo Bakelite Co., Ltd. | 2016 | — |
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 |
|---|---|---|---|
| * | K092309 | Single Use Electrosurgical Knife Series, Model KD-610L, KD-611L, KD-620LR, KD-630L…Summary page 4…at time of Submission 4. Predicate Devices Olympus Medical Systems, Corp. IT Knife/ IT Knife 2/ Hook Knife/ Flex Knife/ Triangle Tip Knife Electrosurgical Knife (K092309) 5. Device Description The SB Knife™ is a single-patient use EtO-sterilized hand-held device that connects to an external… | 2009 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 9, 2016 | Class II | Z-0388-2017 | Error in labeling | Mislabeled product: Sterilization pouch and carton box labeled as Standard type instead of Jr type-Long |
| Sep 9, 2016 | Class II | Z-0389-2017 | Error in labeling | Mislabeled product: Sterilization pouch and carton labeled as Standard Type instead of Short type |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 6 other devices also cite its predicate K092309.
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. 2016, 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™ is a single-use sterile Electrosurgical Knife (Model Numbers: MD-47703W, MD-47704, MD-47706 and MD-47703L). This device is designed to be used with Olympus and ERBE Electrosurgical monopolar HF generators, connectors and patient grounding plates to cut tissue within the digestive tract using high-frequency current.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152771 · printed Nov 5, 2026
Cite this page
510(k) Report. “K152771: SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K152771
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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