510(k) Report

510(k) · Cleared

Cleared

Modification to Hermes Operating Room Control Center

K003222510(k) SpecialCleared Nov 3, 200018-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. · GCI Laryngoscope, Endoscope

Cleared on Nov 3, 2000 after an 18-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.

Decided
Nov 3, 2000
Review
18 days
Class
Class II
Product code
GCI
Recalls
None
Predicates
0

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

Descendants, by year cleared 2002: 2 descendants cleared2003: 6 descendants cleared2006: 1 descendant cleared2005: 1 descendant cleared2009: 1 descendant cleared200020052010201520202025
  1. This deviceK003222 Modification to Hermes Operating Room Control CenterComputer Motion, Inc. · 2000
  2. Descendant · cites it directly · 9 of its ownK023095 Hermes Operating Room Control CenterComputer Motion, Inc. · 2002
  3. Descendant · 2 generations on · 8 of its ownK024294 Modification to Hermes Operating Room Control CenterComputer Motion, Inc. · 2003
  4. Descendant · 3 generations on · 7 of its ownK030240 Modification to Hermes Operating Room Control CenterComputer Motion, Inc. · 2003
  5. Descendant · 4 generations on · 2 of its ownK052740 Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2005
  6. Descendant · 3 generations on · 1 of its ownK060717 Nurse Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2006

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2002: 22003: 62005: 12006: 12009: 1
2002high 6 (2003) · low 0 (2004)2026

Most influential descendants

Showing 5 of 11 · See all
  • K023095Hermes Operating Room Control CenterComputer Motion, Inc. · 2002 · cites it directly9descendants
  • K024294Modification to Hermes Operating Room Control CenterComputer Motion, Inc. · 2003 · 2 generations on8descendants
  • K030240Modification to Hermes Operating Room Control CenterComputer Motion, Inc. · 2003 · 3 generations on7descendants
  • K052740Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2005 · 4 generations on2descendants
  • K060717Nurse Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis) · 2006 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K003222Modification to Hermes Operating Room Control CenterComputer Motion, Inc.2000—
+1K023095Hermes Operating Room Control CenterComputer Motion, Inc.2002—
+2K024294Modification to Hermes Operating Room Control CenterComputer Motion, Inc.2003—
+3K030240Modification to Hermes Operating Room Control CenterComputer Motion, Inc.2003—
+4K052740Nurse's Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis)2005—
+3K060717Nurse Assistant 1.7 O.R. Control SystemConmed Integrated Systems (Cmis)2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200220
200360
200510
200610
200910
FIG. 1 — Lineage of K003222, 2000–2009Source: 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 GCI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin 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? (11)

See all 11

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

NumberDeviceApplicantDecidedDescendants
K023095Hermes Operating Room Control CenterComputer Motion, Inc.20029
K022897Modification to Hermes Operating Room Control CenterComputer Motion, Inc.20020

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?

  • Of its descendants, K023095 (Computer Motion, Inc., 2002) has gone furthest, with 9 descendants of its own.

How does its category compare?

All GCI devices

GCI Laryngoscope, Endoscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GCI

FDA has decided no GCI device since 2007.

Median 510(k) review, days · GCI

Too few GCI 510(k)s in any year since 2007 to give a median.

Recalls per year · GCI

No recall names GCI since 2007.

Adverse event reports per year · GCI

121in 2025

2007: 12008: 22009: 72010: 192011: 492012: 552013: 502014: 1062015: 1772016: 1002017: 1302018: 1022019: 1352020: 1292021: 962022: 1022023: 1012024: 1192025: 121
2007high 177 (2015) · low 1 (2007)2025

MAUDE reports naming product code GCI, 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—01
20080—02
20090—07
20100—019
20110—049
20120—055
20130—050
20140—0106
20150—0177
20160—0100
20170—0130
20180—0102
20190—0135
20200—0129
20210—096
20220—0102
20230—0101
20240—0119
20250—0121
20260—0—

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 GCI

The GCI category page

  • K021747Degall Laparoscopic Gallbladder ExtractorSurgicon, Inc. · 2002
  • K001362Karl Storz 3D Video SystemKarl Storz Imaging, Inc. · 2000
  • K933515Booty Endoscope WarmerT-Med, Inc. · 1993
  • K930302Birtcher Sure Clean Instrument SystemBirtcher Medical Systems, Inc. · 1993
  • K930496GI-1090,1095,1080,1085,1086,1088, Endo. ClampsBirtcher Medical Systems, Inc. · 1993

https://510kreport.com/device/K003222 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003222: Modification to Hermes Operating Room Control Center.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003222

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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