510(k) · Cleared
ClearedArthrocare Coblator IQ System
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 Jan 15, 2010 as substantially equivalent to K030108 (Arthrocare Corp., 2003) and 2 other predicates after a 220-day review. Its family tree reaches back 9 generations to 1994. 1 later device descends from it.
- Decided
- Jan 15, 2010
- Review
- 220 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K936109 (1994). 58 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 5 generations between
- 3 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 2 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 1 generation backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- This deviceK091674 Arthrocare Coblator IQ SystemArthrocare Corp. · 2010
- Descendant · cites it directly · 0 of its ownK123353 Ciq Controller, Ciq WandsArthroCare Corporation · 2013
Show all 9 generations
- Root · 9 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 8 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 7 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 6 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 5 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 4 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 3 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 2 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 1 generation backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- This deviceK091674 Arthrocare Coblator IQ SystemArthrocare Corp. · 2010
Most influential descendants
Showing 1 of 1 · See all- K123353Ciq Controller, Ciq WandsArthroCare Corporation · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −8 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −7 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −6 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −5 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −4 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −3 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −2 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −1 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| 0 (this device) | K091674 | Arthrocare Coblator IQ System | Arthrocare Corp. | 2010 | — |
| +1 | K123353 | Ciq Controller, Ciq Wands | ArthroCare Corporation | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1986 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 8 | 0 |
| 1997 | 2 | 0 |
| 1998 | 6 | 0 |
| 1999 | 1 | 0 |
| 2000 | 7 | 0 |
| 2001 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K030108 | Arthrocare Ent Coblator Surgery SystemSummary page 1…lass II, 21 CFR 878.4400, Product Code 79G - - El) Predicate Devices U ~~ArthroCare Coblator ENT Surgery System K0301 08 (February 3, 2003) ArthroCare 80005 Coblator Surgery System K053297 (December 6, 2005) ArthroCare Irrigation Pump… | 2003 |
| * | K053297 | Arthrocare 8000S Coblator Surgery SystemSummary page 1…0, Product Code 79G - - El) Predicate Devices U ~~ArthroCare Coblator ENT Surgery System K0301 08 (February 3, 2003) ArthroCare 80005 Coblator Surgery System K053297 (December 6, 2005) ArthroCare Irrigation Pump K080482 (March 20, 2008) Product Description The Arthiro… | 2005 |
| * | K080482 | Arthrocare Irrigation Pump, Model SIP001-00, SIP001-01Summary page 1…lator ENT Surgery System K0301 08 (February 3, 2003) ArthroCare 80005 Coblator Surgery System K053297 (December 6, 2005) ArthroCare Irrigation Pump K080482 (March 20, 2008) Product Description The ArthiroCare Coblator IQ System is a bipolar, high frequency, electrosurgical… | 2008 |
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 |
|---|---|---|---|
| K123353 | Ciq Controller, Ciq Wands | 2013 | 0 |
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 16 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 58 ancestors have a recall of any class.
- Of its descendants, K123353 (ArthroCare Corporation, 2013) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K030108.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Coblator IQ System is indicated for the following procedures: *For resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in spinal and neurological procedures; and *For ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: -Adenoidectomy *Cysts *Head, Neck, Oral, and Sinus Surgery *Mastoidectomny *Myringotomy with Effective…
Read the full statement (107 words)
The ArthroCare Coblator IQ System is indicated for the following procedures:
*For resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in spinal and neurological procedures; and
*For ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including:
-Adenoidectomy
*Cysts
*Head, Neck, Oral, and Sinus Surgery
*Mastoidectomny
*Myringotomy with Effective Hemorrhage Control
*Nasal Airway Obstruction by Reduction of Hypertrophic Nasal Turbinates
*Nasopharyngeal/Laryngeal indications including Tracheal Procedures, Laryngeal Polypectomy, and Laryngeal Lesion Debulking
*Neck Mass
*Papilloma Keloids
*Submucosal Palatal Shrinkage
*Submucosal Tissue Shrinkage
Tonsillectomy
*Traditional Uvulopalatoplasty (RAUP)
*Tumors
*Tissue in the Uvula/Soft Palate for the Treatment of Snoring
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091674 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091674: Arthrocare Coblator IQ System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091674
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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