510(k) Report

510(k) · Cleared

Cleared

MKM (Multiple Coordinate Manipulator) System

K942233510(k) TraditionalCleared Jul 1, 199453-day reviewClass I21 CFR 878.4700

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

Carl Zeiss, Inc. · EPT Microscope, Surgical

Cleared on Jul 1, 1994 after a 53-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Jul 1, 1994
Review
53 days
Class
Class I
Product code
EPT
Recalls
None
Predicates
0

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

Descendants, by year cleared 1996: 2 descendants cleared1998: 1 descendant cleared1999: 1 descendant cleared1990200020102020
  1. This deviceK942233 MKM (Multiple Coordinate Manipulator) SystemCarl Zeiss, Inc. · 1994
  2. Descendant · cites it directly · 2 of its ownK961639 Leksell Image Guidance Surgical System (Ligs)Elekta Instrument AB · 1996
  3. Descendant · 2 generations on · 1 of its ownK973684 Leksell Viewscope, Leksell Surgiscope, Leksell FreehandElekta Instrument AB · 1998
  4. Descendant · 3 generations on · 0 of its ownK992882 Leksell Image Guidance Surgical System, View Scope…Elekta Instrument AB · 1999
  5. Descendant · cites it directly · 0 of its ownK961834 Philips Easyguide NeuroPhilips Medical Systems, Inc. · 1996

Most influential descendants

Showing 4 of 4 · See all
  • K961639Leksell Image Guidance Surgical System (Ligs)Elekta Instrument AB · 1996 · cites it directly2descendants
  • K973684Leksell Viewscope, Leksell Surgiscope, Leksell FreehandElekta Instrument AB · 1998 · 2 generations on1descendant
  • K992882Leksell Image Guidance Surgical System, View Scope, Surgiscope,Elekta InsightElekta Instrument AB · 1999 · 3 generations on0descendants
  • K961834Philips Easyguide NeuroPhilips Medical Systems, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K942233MKM (Multiple Coordinate Manipulator) SystemCarl Zeiss, Inc.1994—
+1K961639Leksell Image Guidance Surgical System (Ligs)Elekta Instrument AB1996—
+2K973684Leksell Viewscope, Leksell Surgiscope, Leksell FreehandElekta Instrument AB1998—
+3K992882Leksell Image Guidance Surgical System, View Scope, Surgiscope,Elekta InsightElekta Instrument AB1999—
+1K961834Philips Easyguide NeuroPhilips Medical Systems, Inc.1996—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199620
199810
199910
FIG. 1 — Lineage of K942233, 1994–1999Source: 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 EPT? 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? (4)

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

NumberDeviceApplicantDecidedDescendants
K961639Leksell Image Guidance Surgical System (Ligs)Elekta Instrument AB19962
K961834Philips Easyguide NeuroPhilips Medical Systems, Inc.19960

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, K961639 (Elekta Instrument AB, 1996) has gone furthest, with 2 descendants of its own.

How does its category compare?

All EPT devices

EPT Microscope, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EPT

FDA has decided no EPT device since 2007.

Median 510(k) review, days · EPT

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

Recalls per year · EPT

2in 2022

2009: 12011: 22022: 2
2007high 2 (2011) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · EPT

14in 2025

2007: 172008: 82009: 92010: 62011: 372012: 362013: 272014: 252015: 142016: 132017: 132018: 132019: 152020: 102021: 312022: 422023: 442024: 162025: 14
2007high 44 (2023) · low 6 (2010)2025

MAUDE reports naming product code EPT, 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—017
20080—08
20090—19
20100—06
20110—237
20120—036
20130—027
20140—025
20150—014
20160—013
20170—013
20180—013
20190—015
20200—010
20210—031
20220—242
20230—044
20240—016
20250—014
20260—0—

More from Carl Zeiss, Inc.

51 FDA decisions under this applicant name. See the company

  • K013402Visulas 532SCarl Zeiss, Inc. · 20011 recall
  • K003885Visulas Yag IICarl Zeiss, Inc. · 2001
  • K993357IolmasterCarl Zeiss, Inc. · 20004 recalls
  • K983868Opmi Twiner Surgical MicroscopeCarl Zeiss, Inc. · 1999
  • K965139Surgical Microscope Navigator (SMN) System/Surgical Tool Navigator (STN) SystemCarl Zeiss, Inc. · 1997

Recent decisions in EPT

The EPT category page

  • K931284Microdyne Office Surgical MicroscopeMicrodyne, Inc. · 1993
  • K933310Micrins Contrast Background MaterialMicrins Surgical, Inc. · 1993
  • K903412Storz Model M705 and/or M706 Ceiling Mounted Micr.Storz Instrument Co. · 1990
  • K883581Opmi CSCarl Zeiss, Inc. · 1988
  • K882269Storz Diagnostic Microscope SystemStorz Instrument Co. · 1988

https://510kreport.com/device/K942233 · printed Nov 5, 2026

Cite this page

510(k) Report. “K942233: MKM (Multiple Coordinate Manipulator) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K942233

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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