510(k) · Cleared
ClearedDiathermic Slitter (FlushKnife) DK2620JI and DK2623JI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Corporation · KGE Forceps, Biopsy, Electric
Cleared on Feb 4, 2022 as substantially equivalent to K171096 (Fujifilm Medical Systems U.S.A, Inc., 2017) after a 29-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Feb 4, 2022
- Review
- 29 days
- Class
- Class II
- Product code
- KGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K955052 (1996). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK955052 Olympus FD-1/2-1 Hot Biopsy ForcepsOlympus America, Inc. · 1996
- 4 generations backK062517 Electrosurgical Hemostatic Forceps SeriesOlympus Medical Systems Corporation · 2006
- 3 generations backK151474 Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter…Fujifilm Medical System U.S.A., Inc. · 2016
- 2 generations backK161186 Fujifilm Diathermic Slitter (FlushKnife), Fujifilm Diathermic…Fujifilm Medical Systems U.S.A, Inc. · 2016
- 1 generation backK171096 Fujifilm Diathermic Slitter (FlushKnife)Fujifilm Medical Systems U.S.A, Inc. · 2017
- This deviceK220053 Diathermic Slitter (FlushKnife) DK2620JI and DK2623JIFujifilm Corporation · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K955052 | Olympus FD-1/2-1 Hot Biopsy Forceps | Olympus America, Inc. | 1996 | — |
| −4 | K062517 | Electrosurgical Hemostatic Forceps Series | Olympus Medical Systems Corporation | 2006 | — |
| −3 | 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 | — |
| −1 | K171096 | Fujifilm Diathermic Slitter (FlushKnife) | Fujifilm Medical Systems U.S.A, Inc. | 2017 | — |
| 0 (this device) | K220053 | Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI | Fujifilm Corporation | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2009 | 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 KGE? 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 KGE device
- #1 K251807 Single Use Electrosurgical Hemostatic Forceps…score 11.6 · 3 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 |
|---|---|---|---|
| * | K171096 | Fujifilm Diathermic Slitter (FlushKnife)Summary page 4…21 C.F.R. § 876.4300 Review Panel: Gastroenterology/Urology Predicate Device: x FUJIFILM Diathermic Slitter FlushKnife (K171096) Intended Use / Indications for Use: These products are used in combination with an applicable endoscope to perform the endosco… | 2017 |
| † | K150852 | SIC 8000 | 2015 |
| † | K180068 | ORISE Gel | 2018 |
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 26 years and passes through 5 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All KGE devicesKGE Forceps, Biopsy, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · KGE
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KGE
184in 2018
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KGE
No recall names KGE since 2007.
Adverse event reports per year · KGE
10in 2025
MAUDE reports naming product code KGE, 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 | 4 |
| 2008 | 0 | — | 0 | 15 |
| 2009 | 2 | — | 0 | 75 |
| 2010 | 1 | — | 0 | 29 |
| 2011 | 0 | — | 0 | 51 |
| 2012 | 0 | — | 0 | 30 |
| 2013 | 1 | — | 0 | 14 |
| 2014 | 1 | — | 0 | 12 |
| 2015 | 0 | — | 0 | 15 |
| 2016 | 3 | 102 | 0 | 9 |
| 2017 | 2 | — | 0 | 26 |
| 2018 | 3 | 184 | 0 | 26 |
| 2019 | 1 | — | 0 | 15 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 2 | — | 0 | 24 |
| 2022 | 1 | — | 0 | 16 |
| 2023 | 1 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 9 |
| 2025 | 2 | — | 0 | 10 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
These products are used in combination with an applicable endoscope to perform the endoscopic treatments for the target site in the gastrointestinal tract, such as ablation, incision, dissection, cauterization, coagulation and avulsion of tissue and arrest of bleeding, and to inject saline or submucosal injection agent for endoscopic surgery into the submucosal layer in the gastrointestinal tract, which is exposed after dissection, under the management of physicians in medical facilities. Never use this product for any other purpose.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220053 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220053: Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220053
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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