510(k) · Cleared
ClearedTransferMan 4m Micromanipulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eppendorf AG · MQJ Micromanipulators And Microinjectors, Assisted Reproduction
Cleared on Jan 23, 2015 as substantially equivalent to K113712 (Narishige Co., Ltd., 2012) and 1 other predicate after a 165-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Jan 23, 2015
- Review
- 165 days
- Class
- Class II
- Product code
- MQJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K001910 (2000). 5 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001910 | IM-9C Microinjectors | Narishige Co., Ltd. | 2000 | — |
| −1 | K113712 | IM-11 Pneumatic Microinjector | Narishige Co., Ltd. | 2012 | — |
| 0 (this device) | K142207 | TransferMan 4m Micromanipulator | Eppendorf AG | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2012 | 1 | 0 |
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 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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K113712 | IM-11 Pneumatic MicroinjectorSummary page 4…other legally marketed assisted reproduction micromanipulators and microinjectors including the following: • IM-11 Pneumatic Microinjector (Narishige Co., Ltd., K113712) • NAI-5 Micromanipulator Set (Narishige Co., Ltd., K120877)* * Eppendorf is claiming substantial equivalence of the… | 2012 |
| * | K120877 | Micromanipulator SetSummary page 4…and microinjectors including the following: • IM-11 Pneumatic Microinjector (Narishige Co., Ltd., K113712) • NAI-5 Micromanipulator Set (Narishige Co., Ltd., K120877)* * Eppendorf is claiming substantial equivalence of the proposed TransferMan® 4m Micromanipulator only to the Micr… | 2012 |
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 15 years and passes through 2 companies; a new generation was cleared every 11.7 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All MQJ devicesMQJ Micromanipulators And Microinjectors, Assisted Reproduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · MQJ
1in 2015
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
MAUDE reports naming product code MQJ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The TransferMan® 4m Micromanipulator is intended for use in assisted reproduction procedures requiring coarse and fine positioning of a microtool under the microscope.
The CellTram® Microinjectors are intended for use in Intra-Cytoplasmic Spermatozoa Injection (ICSI) procedures to aspirate and inject sperm into oocytes.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142207 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142207: TransferMan 4m Micromanipulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142207
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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