510(k) · Cleared
Recalled · Class II · 2024Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Olympus Medical Systems Corp. · KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Cleared on May 15, 2019 as substantially equivalent to K171158 (Olympus Medical Systems Corp., 2017) after a 253-day review. Its family tree reaches back 9 generations to 1995. 1 later device descends from it. It has been recalled 3 times.
- Decided
- May 15, 2019
- Review
- 253 days
- Class
- Class II
- Product code
- KNS
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 9 generations to K952726 (1995). 32 ancestors in all, the oldest K894762 (1989). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK952726 Ultracision Harmonic ScapelUltracision, Inc. · 1995
- 5 generations between
- 3 generations backK083608 Erbe Hybrid KnifeErbe USA, Inc. · 2009
- 2 generations backK143306 ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc. · 2015
- 1 generation backK171158 Single Use Electrosurgical knifeOlympus Medical Systems Corp. · 2017 · Recalled
- This deviceK182408 Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical…Olympus Medical Systems Corp. · 2019
- Descendant · cites it directly · 0 of its ownK250351 Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use…Olympus Medical Systems Corporation · 2025
Show all 9 generations
- Root · 9 generations backK952726 Ultracision Harmonic ScapelUltracision, Inc. · 1995
- 8 generations backK990430 Ultracision Harmonic Scalpel Hand PieceEthicon Endo-Surgery, Inc. · 1999
- 7 generations backK012464 Helix Hydro-JetAndreas Pein Medizintechnik GmbH · 2001
- 6 generations backK022613 Helix Hydro-JetErbe USA, Inc. · 2002
- 5 generations backK033590 Erbe Helix Hydro-JetErbe USA, Inc. · 2004
- 4 generations backK062712 Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094Erbe USA, Inc. · 2007
- 3 generations backK083608 Erbe Hybrid KnifeErbe USA, Inc. · 2009
- 2 generations backK143306 ERBE WaterJet Model ERBEJET® 2 System with HybridAPC ProbeErbe USA, Inc. · 2015
- 1 generation backK171158 Single Use Electrosurgical knifeOlympus Medical Systems Corp. · 2017 · Recalled
- This deviceK182408 Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical…Olympus Medical Systems Corp. · 2019
Most influential descendants
Showing 1 of 1 · See all- K250351Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife…Olympus Medical Systems Corporation · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K952726 | Ultracision Harmonic Scapel | Ultracision, Inc. | 1995 | — |
| −8 | K990430 | Ultracision Harmonic Scalpel Hand Piece | Ethicon Endo-Surgery, Inc. | 1999 | — |
| −7 | K012464 | Helix Hydro-Jet | Andreas Pein Medizintechnik GmbH | 2001 | — |
| −6 | K022613 | Helix Hydro-Jet | Erbe USA, Inc. | 2002 | — |
| −5 | K033590 | Erbe Helix Hydro-Jet | Erbe USA, Inc. | 2004 | — |
| −4 | K062712 | Erbe Monopolar Attachment for Helix Hydro-Jet, Model P/N 20139-094 | Erbe USA, Inc. | 2007 | — |
| −3 | K083608 | Erbe Hybrid Knife | Erbe USA, Inc. | 2009 | — |
| −2 | K143306 | ERBE WaterJet Model ERBEJET® 2 System with HybridAPC Probe | Erbe USA, Inc. | 2015 | — |
| −1 | K171158 | Single Use Electrosurgical knife | Olympus Medical Systems Corp. | 2017 | 2 |
| 0 (this device) | K182408 | Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife… | Olympus Medical Systems Corp. | 2019 | — |
| +1 | K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use… | Olympus Medical Systems Corporation | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K171158 | Single Use Electrosurgical knifeSummary page 5…Device name 510(k) Submitter 510(k) No. Single Use Electrosurgical knife OLYMPUS MEDICAL K171158 KD-655 SYSTEMS CORP. 2) Reference device Table 12-2 Reference device… | 2017 |
| † | K092309 | Single Use Electrosurgical Knife Series, Model KD-610L, KD-611L, KD-620LR, KD-630L… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250351 | Single Use Electrosurgical Knife (KD-612L, KD-612U); Single Use Electrosurgical Knife… | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 1, 2024 | Class II | Z-1547-2024 | Use error | Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with the Instructions for Use, which… |
| Mar 1, 2024 | Class II | Z-1548-2024 | Use error | Due to increase in complaints for the KD-640L and KD-645L Triangle Tip Electrosurgical Knives breaking off during use -issuing reminder to users to utilize the electrosurgical knife in accordance with the Instructions for Use, which… |
| Feb 17, 2024 | Class II | Z-1223-2026 | Device Design | A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 32 ancestors have a recall of any class.
- Of its descendants, K250351 (Olympus Medical Systems Corporation, 2025) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K171158.
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. 2019, 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?
KD-625
These instruments have been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the digestive tract.
These instruments are indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope.
KD-645
This instrument has been designed to be used with Olympus endoscopes and electrosurgical units to cut tissue using high-frequency current within the digestive tract.
This instrument is indicated for the induction of sterile normal saline into the submucosa to lift mucosal lesions using direct visualization through an endoscope.
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/K182408 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182408: Single Use Electrosurgical Knife KD-625 , Single Use Electrosurgical Knife KD-645.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182408
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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