510(k) · Cleared
Recalled · Class II · 2024Single Use Electrosurgical Knife Series, Model KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corporation · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on Oct 30, 2009 after a 92-day review. The FDA summary names its predicate without a number. 15 later devices descend from it. It has been recalled 9 times.
- Decided
- Oct 30, 2009
- Review
- 92 days
- Class
- Class II
- Product code
- KNS
- Recalls
- 9
- Predicates
- 0
15 later devices descend from it, 7 citing it directly.
- This deviceK092309 Single Use Electrosurgical Knife Series, Model KD-610L, KD-611L…Olympus Medical Systems Corporation · 2009
- Descendant · cites it directly · 7 of its ownK171158 Single Use Electrosurgical knifeOlympus Medical Systems Corp. · 2017 · Recalled
- Descendant · cites it directly · 3 of its ownK151474 Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter…Fujifilm Medical System U.S.A., Inc. · 2016
- Descendant · 2 generations on · 2 of its ownK161186 Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic…Fujifilm Medical Systems U.S.A, Inc. · 2016
- Descendant · 2 generations on · 1 of its ownK193601 Single Use Electrosurgical KnifeMicro-Tech (Nanjing) Co., Ltd. · 2020
- Descendant · 2 generations on · 1 of its ownK182408 Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical…Olympus Medical Systems Corp. · 2019 · Recalled
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K171158Single Use Electrosurgical knifeOlympus Medical Systems Corp. · 2017 · cites it directly7descendants
- K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter)Fujifilm Medical System U.S.A., Inc. · 2016 · cites it directly3descendants
- K161186Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter (ClutchCutter)Fujifilm Medical Systems U.S.A, Inc. · 2016 · 2 generations on2descendants
- K193601Single Use Electrosurgical KnifeMicro-Tech (Nanjing) Co., Ltd. · 2020 · 2 generations on1descendant
- K182408Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645Olympus Medical Systems Corp. · 2019 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K092309 | Single Use Electrosurgical Knife Series, Model KD-610L, KD-611L, KD-620LR… | Olympus Medical Systems Corporation | 2009 | — |
| +1 | K171158 | Single Use Electrosurgical knife | Olympus Medical Systems Corp. | 2017 | 2 |
| +1 | K151474 | Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) | Fujifilm Medical System U.S.A., Inc. | 2016 | — |
| +2 | K161186 | Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic Slitter… | Fujifilm Medical Systems U.S.A, Inc. | 2016 | — |
| +2 | K193601 | Single Use Electrosurgical Knife | Micro-Tech (Nanjing) Co., Ltd. | 2020 | — |
| +2 | K182408 | Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife… | Olympus Medical Systems Corp. | 2019 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 3 | 0 |
| 2017 | 3 | 0 |
| 2019 | 1 | 0 |
| 2020 | 4 | 0 |
| 2021 | 1 | 0 |
| 2022 | 2 | 0 |
| 2025 | 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 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 |
|---|---|---|---|
| * | — | KD-IL-1 Named without a submission number |
What descends from it? (15)
See all 157 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K171158 | Single Use Electrosurgical knife | 2017 | 7 |
| K151474 | Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) | 2016 | 3 |
| K171983 | Creo Medical Electrosurgical System including Speedboat RS2 Surgical Accessory | 2017 | 1 |
| K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife… | 2025 | 0 |
| K212999 | Multi-Functional Electrosurgical Knife | 2022 | 0 |
| K192342 | Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare… | 2020 | 0 |
| K152771 | SB Knife Jr type, SB Knife Short type, SB Knife Standard type, SB Knife Jr type - Long | 2016 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 17, 2024 | Class II | Z-1222-2026 | Device Design | A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use. |
| Jan 4, 2021 | Class II | Z-0980-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-0977-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-0976-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-0974-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-0975-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-0978-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-0979-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
| Jan 4, 2021 | Class II | Z-0981-2021 | Under Investigation by firm | Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used. |
The 5 latest of 9 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K171158 (Olympus Medical Systems Corp., 2017) has gone furthest, with 7 descendants of its own.
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. 2009, 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?
Singqle Use Electrosurgical Knife KD-610OL/KD-61 IL/KD-620LR/KD-63OL/KD-640L
This instrument has been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue within the digestive tract using high-frequency current.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092309 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092309: Single Use Electrosurgical Knife Series, Model KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092309
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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