510(k) · Cleared
ClearedArthrocare Irrigation Pump, Model SIP001-00, SIP001-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Arthrocare Corp. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Mar 20, 2008 as substantially equivalent to K001904 (Arthrocare Corp., 2000) after a 27-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Mar 20, 2008
- Review
- 27 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001904 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK001904 Arthrocare Flow Control UnitArthrocare Corp. · 2000
- This deviceK080482 Arthrocare Irrigation Pump, Model SIP001-00, SIP001-01Arthrocare Corp. · 2008
- Descendant · cites it directly · 1 of its ownK091674 Arthrocare Coblator IQ SystemArthrocare Corp. · 2010
- Descendant · 2 generations on · 0 of its ownK123353 Ciq Controller, Ciq WandsArthroCare Corporation · 2013
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001904 | Arthrocare Flow Control Unit | Arthrocare Corp. | 2000 | — |
| 0 (this device) | K080482 | Arthrocare Irrigation Pump, Model SIP001-00, SIP001-01 | Arthrocare Corp. | 2008 | — |
| +1 | K091674 | Arthrocare Coblator IQ System | Arthrocare Corp. | 2010 | — |
| +2 | K123353 | Ciq Controller, Ciq Wands | ArthroCare Corporation | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K001904 | Arthrocare Flow Control UnitSummary page 1…re Irrigation Pump Generic/Common Name: Electrosurgical Device and Accessories Predicate Devices · ArthroCare Flow Control Unit K001904; cleared July 17, 2000 Intended Use The ArthroCare Irrigation Pump is an accessory, supplied separately, that can be used with t… | 2000 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091674 | Arthrocare Coblator IQ System | 2010 | 1 |
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?
- Its one ancestor has no recall.
- Of its descendants, K091674 (Arthrocare Corp., 2010) has gone furthest, with 1 descendant of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
The ArthroCare Irrigation Pump is an accessory, supplied separately, that can be used with the following Electrosurgery Systems for the referenced indications:
The ArtiroCare ENT Coblator Surgery System is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery.
The ArthroCare Orthopedic Electrosurgery System is indicated for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in orthopedic, arthroscopic, spinal, and neurosurgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080482 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080482: Arthrocare Irrigation Pump, Model SIP001-00, SIP001-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080482
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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