510(k) Report

510(k) · Cleared

Cleared

Zeus Microwrist Robotic Surgical System and Accessories

K021152510(k) TraditionalCleared Sep 24, 2002167-day reviewClass II21 CFR 876.1500

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

Computer Motion, Inc. · NAY System, Surgical, Computer Controlled Instrument

Cleared on Sep 24, 2002 as substantially equivalent to K990144 (Intuitive Surgical, Inc., 2000) after a 167-day review. Its family tree reaches back 3 generations to 1994.

Decided
Sep 24, 2002
Review
167 days
Class
Class II
Product code
NAY
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K930667 (1994). 5 ancestors in all, the oldest K931340 (1993). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1993: 1 other ancestor1994: 1 other ancestorK930667 · Reusable Laparoscopic Instruments · Snowden-Pencer · 1994 · recalledK960400 · Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port (Access Parts) · Snowden-Pencer · 1996K990144 · Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System · Intuitive Surgical, Inc. · 2000 · recalled19901992199419961998200020022004
Other ancestors, by generation 2 generations back: 1 other ancestor3 generations back: 1 other ancestor K990144 · Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument Control System · Intuitive Surgical, Inc. · 2000 · recalledK960400 · Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line Instruments/Diamond-Port (Access Parts) · Snowden-Pencer · 1996K930667 · Reusable Laparoscopic Instruments · Snowden-Pencer · 1994 · recalled0
  1. Root · 3 generations backK930667 Reusable Laparoscopic InstrumentsSnowden-Pencer · 1994 · Recalled
  2. 2 generations backK960400 Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer · 1996
  3. 1 generation backK990144 Intuitive Surgical Endoscopic Instruments, Intuitive Surgical…Intuitive Surgical, Inc. · 2000 · Recalled
  4. This deviceK021152 Zeus Microwrist Robotic Surgical System and AccessoriesComputer Motion, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K930667Reusable Laparoscopic InstrumentsSnowden-Pencer199415
−2K960400Diamond-Touch and Micro Diamond-Touch Instruments/Diamond-Line…Snowden-Pencer1996—
−1K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic…Intuitive Surgical, Inc.20003
0 (this device)K021152Zeus Microwrist Robotic Surgical System and AccessoriesComputer Motion, Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199310
199410
FIG. 1 — Lineage of K021152, 1994–2002Source: 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), 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 NAY? 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 NAY device

  1. #1 K232610 da Vinci Surgical System Model IS5000, da…score 32.9 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (2)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K990144Intuitive Surgical Endoscopic Instruments, Intuitive Surgical Endoscopic Instrument…
Summary page 1
…minimally invasive surgical instruments 2. The Intuitive Surgical da VinciTMEndoscopic Instrument Control System and Endoscopic Instruments, cleared to market via IC990144. 4) Description of the Device: The ZEUS@MicroWrist'" Surgical System (ZEUS System) and Accessories, consisting of a surge…
Intuitive Surgical, Inc.20003
*—A standard laparoscope with hand-held minimally invasive surgical instruments
Named without a submission number
—

Also cleared against K990144: 20 other devices →

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 8 years and passes through 3 companies; a new generation was cleared every 2.2 years on median.
  • 2 of the 5 ancestors have a recall of any class.
  • 20 other devices also cite its predicate K990144.

How does its category compare?

All NAY devices

NAY System, Surgical, Computer Controlled Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NAY

16in 2025

2008: 42009: 32010: 12011: 72012: 42013: 42014: 92015: 32016: 82017: 162018: 152019: 82020: 92021: 112022: 62023: 52024: 102025: 162026 (partial year): 7
2007high 16 (2017) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NAY

117in 2025

2008: 189 days median2009: 253 days median2011: 191 days median2012: 106 days median2013: 144 days median2014: 143 days median2015: 99 days median2016: 197 days median2017: 107 days median2018: 152 days median2019: 73 days median2020: 212 days median2021: 61 days median2022: 57 days median2023: 141 days median2024: 126 days median2025: 117 days median2026 (partial year): 89 days median
2007high 253 (2009) · low 57 (2022)2026

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

Recalls per year · NAY

1in 2025

2007: 112008: 32009: 12011: 22012: 12013: 62014: 252015: 32016: 12017: 12018: 22019: 52021: 32022: 32023: 2, 1 Class I2024: 402025: 12026 (partial year): 4, 1 Class I
2007high 40 (2024) · low 0 (2010)2026

Class I (2 since 2007) Class II/III not classified

Adverse event reports per year · NAY

48,456in 2025

2007: 1332008: 2242009: 3802010: 6232011: 5012012: 1,5522013: 6,2172014: 6,1352015: 1,7222016: 1,0772017: 1,0492018: 1,0742019: 1,1542020: 1,5582021: 1,9972022: 5,7272023: 10,8982024: 12,8722025: 48,456
2007high 48,456 (2025) · low 133 (2007)2025

MAUDE reports naming product code NAY, 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
20070—11133
200841893224
200932531380
20101—0623
201171912501
2012410611,552
2013414466,217
20149143256,135
201539931,722
2016819711,077
20171610711,049
20181515221,074
201987351,154
2020921201,558
2021116131,997
202265735,727
202351412 (1)10,898
2024101264012,872
202516117148,456
20267894 (1)—

What is it indicated for?

The ZEUS' MicroWristTMSurgical System (ZEUS System) and Accessories are intended to be used to assist a surgeon during procedures such as Laparoscopic Cholecystectomy and Nissen Fundoplication, to hold and position an endoscope, and to control laparoscopic instruments in performance of the surgical tasks of grasping, sharp cutting, blunt dissection, electro-cautery and suturing with knot placement. The ZEUS System is intended to be used by surgeons who…

Read the full statement (124 words)

The ZEUS' MicroWristTMSurgical System (ZEUS System) and Accessories are intended

to be used to assist a surgeon during procedures such as Laparoscopic Cholecystectomy

and Nissen Fundoplication, to hold and position an endoscope, and to control

laparoscopic instruments in performance of the surgical tasks of grasping, sharp cutting,

blunt dissection, electro-cautery and suturing with knot placement. The ZEUS System is

intended to be used by surgeons who are trained in minimally invasive surgery, have

successfully completed a ZEUS System training program, and are certified in accordance

with their respective hospital's customary practice for ZEUS System use. The ZEUS@

MicroWristTMSurgical System is intended to be used in an operating room environment

in which the ZEUS System, the operating surgeon and patient are in the same room.

Indications for use as stated in the FDA summary.

Also cleared against K990144

20 other devices cite the same predicate.

  • K123329DA Vinvi Surgical SystemIntuitive Surgical, Inc. · 2014
  • K1017435MM Flared Cannula Model 420262, 8MM Flared Cannula Model 420319Intuitive Surgical, Inc. · 20111 recall
  • K090993Intuitive Surgical Endoscopic Instrument Control Systems, Models IS1200, IS2000 and IS3000Intuitive Surgical, Inc. · 20093 recalls
  • K070947Intuitive Surgical DA Vinci Surgical System and Endoscopic Instruments and Endowrist Cardiac Probe GrasperIntuitive Surgical, Inc. · 20081 recall
  • K072627Intuitive Surgical DA Vinci and DA Vinci S Surgical System and Endoscopic Instruments and Endowrist IntroducerIntuitive Surgical, Inc. · 2008
  • K061260Intuitive Surgical Endowrist PK Dissecting Forceps, Models 400214 & 420214Intuitive Surgical, Inc. · 20061 recall

More from Computer Motion, Inc.

26 FDA decisions under this applicant name. See the company

  • K031956Modification to Hermes O.R. Control CenterComputer Motion, Inc. · 2003
  • K031720Modification to Hermes O.R. Control CenterComputer Motion, Inc. · 2003
  • K031382Modification to Hermes O.R. Control CenterComputer Motion, Inc. · 2003
  • K030578Bipolar Grasper and Bipolar Scissors for the Zeus Microwrist Surgical SystemComputer Motion, Inc. · 2003
  • K030718SCB Computer Motion Interface ControllerComputer Motion, Inc. · 2003

Recent decisions in NAY

The NAY category page

  • K261823da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc. · 2026
  • K261824da Vinci Surgical System, Model IS5000Intuitive Surgical, Inc. · 2026
  • K260695da Vinci Firefly Imaging SystemIntuitive Surgical · 2026
  • K254192Senhance Ultrasonic SystemAsensus Surgical · 2026
  • K253986da Vinci Force Feedback InstrumentsIntuitive Surgical, Inc. · 2026

https://510kreport.com/device/K021152 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021152: Zeus Microwrist Robotic Surgical System and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021152

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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