510(k) Report

510(k) · Cleared

Cleared

Motor-Drive Manipulator MM-89

K002291510(k) TraditionalCleared Sep 13, 200048-day reviewClass II21 CFR 884.6150

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

Narishige Co., Ltd. · MQJ Micromanipulators And Microinjectors, Assisted Reproduction

Cleared on Sep 13, 2000 after a 48-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Sep 13, 2000
Review
48 days
Class
Class II
Product code
MQJ
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2012: 1 descendant cleared2015: 1 descendant cleared200020052010201520202025
  1. This deviceK002291 Motor-Drive Manipulator MM-89Narishige Co., Ltd. · 2000
  2. Descendant · cites it directly · 1 of its ownK120877 Micromanipulator SetNarishige Co., Ltd. · 2012
  3. Descendant · 2 generations on · 0 of its ownK142207 TransferMan 4m MicromanipulatorEppendorf AG · 2015

Most influential descendants

Showing 2 of 2 · See all
  • K120877Micromanipulator SetNarishige Co., Ltd. · 2012 · cites it directly1descendant
  • K142207TransferMan 4m MicromanipulatorEppendorf AG · 2015 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K002291Motor-Drive Manipulator MM-89Narishige Co., Ltd.2000—
+1K120877Micromanipulator SetNarishige Co., Ltd.2012—
+2K142207TransferMan 4m MicromanipulatorEppendorf AG2015—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201510
FIG. 1 — Lineage of K002291, 2000–2015Source: 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 MQJ? 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? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K120877Micromanipulator SetNarishige Co., Ltd.20121

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, K120877 (Narishige Co., Ltd., 2012) has gone furthest, with 1 descendant of its own.

How does its category compare?

All MQJ devices

MQJ Micromanipulators And Microinjectors, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MQJ

1in 2015

2012: 22015: 1
2007high 2 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MQJ

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

Recalls per year · MQJ

No recall names MQJ since 2007.

Adverse event reports per year · MQJ

1in 2022

2022: 1
2007high 1 (2022) · low 0 (2007)2025

MAUDE reports naming product code MQJ, 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—00
20080—00
20090—00
20100—00
20110—00
20122—00
20130—00
20140—00
20151—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—01
20230—00
20240—00
20250—00
20260—0—
Cite this page

510(k) Report. “K002291: Motor-Drive Manipulator MM-89.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K002291

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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