510(k) Report

510(k) · Cleared

Recalled · Class II · 2019

Rita Starburst Xli Electrosurgical Device

K010060510(k) TraditionalCleared Jan 23, 200115-day reviewClass II21 CFR 878.4400Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Rita Medical Systems · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Jan 23, 2001 after a 15-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 27 later devices descend from it. It has been recalled 3 times.

Decided
Jan 23, 2001
Review
15 days
Class
Class II
Product code
GEI
Recalls
3
Predicates
0

27 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2007: 3 descendants cleared2008: 4 descendants cleared2009: 1 descendant cleared2011: 1 descendant cleared2017: 1 descendant cleared2019: 2 descendants cleared2015: 1 descendant cleared2024: 4 descendants cleared2020: 1 descendant cleared2023: 2 descendants cleared2022: 2 descendants cleared2025: 1 descendant cleared2026: 4 descendants cleared200020052010201520202025
  1. This deviceK010060 Rita Starburst Xli Electrosurgical DeviceRita Medical Systems · 2001
  2. Descendant · cites it directly · 22 of its ownK070101 Uniblate Electrosurgical DeviceRita Medical Systems, Inc. · 2007
  3. Descendant · 2 generations on · 11 of its ownK080376 Oncobionic SystemOncobionic Incorporated · 2008 · Recalled
  4. Descendant · 3 generations on · 10 of its ownK102329 Nanoknife SystemAngioDynamics, Inc. · 2011 · Recalled
  5. Descendant · 4 generations on · 8 of its ownK150089 NanoKnife SystemAngioDynamics, Inc. · 2015 · Recalled
  6. Descendant · 2 generations on · 8 of its ownK080451 Uniblate Electrosurgical DeviceAngioDynamics, Inc. · 2008

Showing 5 of 27 descendants. See all descendants

Descendants cleared per year

2007: 32008: 42009: 12011: 12015: 12017: 12019: 22020: 12022: 22023: 22024: 42025: 12026: 4
2007high 4 (2008) · low 0 (2010)2026

Most influential descendants

Showing 5 of 27 · See all
  • K070101Uniblate Electrosurgical DeviceRita Medical Systems, Inc. · 2007 · cites it directly22descendants
  • K080376Oncobionic SystemOncobionic Incorporated · 2008 · 2 generations on11descendants
  • K102329Nanoknife SystemAngioDynamics, Inc. · 2011 · 3 generations on10descendants
  • K150089NanoKnife SystemAngioDynamics, Inc. · 2015 · 4 generations on8descendants
  • K080451Uniblate Electrosurgical DeviceAngioDynamics, Inc. · 2008 · 2 generations on8descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K010060Rita Starburst Xli Electrosurgical DeviceRita Medical Systems2001—
+1K070101Uniblate Electrosurgical DeviceRita Medical Systems, Inc.2007—
+2K080376Oncobionic SystemOncobionic Incorporated20081
+3K102329Nanoknife SystemAngioDynamics, Inc.20111
+4K150089NanoKnife SystemAngioDynamics, Inc.20151
+2K080451Uniblate Electrosurgical DeviceAngioDynamics, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200730
200840
200910
201110
201510
201710
201920
202010
202220
202320
202440
202510
202640
FIG. 1 — Lineage of K010060, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (27)

See all 27

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K070101Uniblate Electrosurgical DeviceRita Medical Systems, Inc.200722
K070711Incircle BI-Polar RF Ablation SystemRfa Medical, Inc.20073

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Oct 2, 2019Class IIZ-0411-2020Under Investigation by firmThe devices are not labelled correctly. End users impacted by this issue may experience a procedural delay.
May 2, 2006Not classifiedZ-0887-06OtherMisbranding; Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker.
May 2, 2006Not classifiedZ-0888-06OtherMisbranding; Product may have the wrong device handle which incorrectly identifies the product and also has incorrect deployment depth marker

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K070101 (Rita Medical Systems, Inc., 2007) has gone furthest, with 22 descendants of its own.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

More from Rita Medical Systems

11 FDA decisions under this applicant name. See the company

  • K062935Habib 4X LaparoscopicRita Medical Systems · 2006
  • K040989Rita SystemsRita Medical Systems · 20041 recall
  • K030967Rita Starburst Sde Electrosurgical DeviceRita Medical Systems · 2003
  • K023846MR Compatible Rita Model 90 Electosurgical AccessoryRita Medical Systems · 2002
  • K021329Rita SystemRita Medical Systems · 2002

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https://510kreport.com/device/K010060 · printed Nov 3, 2026

Cite this page

510(k) Report. “K010060: Rita Starburst Xli Electrosurgical Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K010060

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026