510(k) · Cleared
ClearedDELPHI System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
CnS Medical Co., Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jun 6, 2025 as substantially equivalent to K220563 (ArthroCare Corporation, 2022) after a 255-day review. Its family tree reaches back 8 generations to 2001.
- Decided
- Jun 6, 2025
- Review
- 255 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K011083 (2001). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK011083 Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord &…Arthrocare Corp. · 2001
- 7 generations backK013463 Arthrocare Arthro Wands, Enetec Evac Plasma WandArthrocare Corp. · 2001
- 6 generations backK020557 Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord…Arthrocare Corp. · 2002
- 5 generations backK030551 Arthrocare Controller (System 2000 and 8000); Arthrocare Patient…Arthrocare Corp. · 2003 · Recalled
- 4 generations backK032504 Arthrocare SystemArthrocare Corp. · 2003
- 3 generations backK071709 Arthrocare System 12000Arthrocare Corp. · 2007
- 2 generations backK082666 Arthrocare Controller (System 12000), Arthrocare Patient Cable, Foot…Arthrocare Corp. · 2008
- 1 generation backK220563 Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000…ArthroCare Corporation · 2022
- This deviceK242907 DELPHI SystemCnS Medical Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K011083 | Arthrocare System 2000 Controller, Cable, Footswitch, Power Cord & Arthrocare… | Arthrocare Corp. | 2001 | — |
| −7 | K013463 | Arthrocare Arthro Wands, Enetec Evac Plasma Wand | Arthrocare Corp. | 2001 | — |
| −6 | K020557 | Arthrocare Controller; Arthrocare Cable; Foot Control; Power Cord; Wands | Arthrocare Corp. | 2002 | — |
| −5 | K030551 | Arthrocare Controller (System 2000 and 8000); Arthrocare Patient Cable; Foot… | Arthrocare Corp. | 2003 | 1 |
| −4 | K032504 | Arthrocare System | Arthrocare Corp. | 2003 | — |
| −3 | K071709 | Arthrocare System 12000 | Arthrocare Corp. | 2007 | — |
| −2 | K082666 | Arthrocare Controller (System 12000), Arthrocare Patient Cable, Foot Control… | Arthrocare Corp. | 2008 | — |
| −1 | K220563 | Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION… | ArthroCare Corporation | 2022 | — |
| 0 (this device) | K242907 | DELPHI System | CnS Medical Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2016 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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 |
|---|---|---|---|
| * | K220563 | Ambient HipVac 50 Wand with Integrated Finger Switches, RF20000 COBLATION System…Summary page 5…s, Device Name RF20000 COBLATION System, WEREWOLF COBLATION system, WEREWOLF+COBLATION System 510(k) number K220563 1/5 K242907 5. Description DELP… | 2022 |
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 24 years and passes through 3 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 10 ancestors has a recall of any class.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
DELPHI System is indicated for coagulation and ablation of tissue and hemostasis of blood vessels during arthroscopic surgery. DELPHI System is designed for exclusive use with DELPHI PLUS or DISCORE bipolar electrode.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242907 · printed Nov 5, 2026
Cite this page
510(k) Report. “K242907: DELPHI System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242907
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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