510(k) · Cleared
ClearedIM-11 Pneumatic Microinjector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Narishige Co., Ltd. · MQJ Micromanipulators And Microinjectors, Assisted Reproduction
Cleared on Mar 15, 2012 as substantially equivalent to K001910 (Narishige Co., Ltd., 2000) after an 87-day review. Its family tree reaches back 1 generation to 2000. 1 later device descends from it.
- Decided
- Mar 15, 2012
- Review
- 87 days
- Class
- Class II
- Product code
- MQJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001910 (2000). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K142207TransferMan 4m MicromanipulatorEppendorf AG · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001910 | IM-9C Microinjectors | Narishige Co., Ltd. | 2000 | — |
| 0 (this device) | K113712 | IM-11 Pneumatic Microinjector | Narishige Co., Ltd. | 2012 | — |
| +1 | K142207 | TransferMan 4m Micromanipulator | Eppendorf AG | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (1)
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 |
|---|---|---|---|
| * | K001910 | IM-9C MicroinjectorsSummary page 1…Narishige Co., Ltd. claims the TM-li Pneumatic Microinjector as substantially equivalent to predicate the IM-9C Pneumatic Injector, Premarket Notification 510(k) Number: K001910. Device Description: The TM-il Pneumatic Microinjector is used for Intracytoplasmic Sperm Injection (ICST) procedures to aspira… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142207 | TransferMan 4m Micromanipulator | 2015 | 0 |
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?
- Its one ancestor has no recall.
- Of its descendants, K142207 (Eppendorf AG, 2015) has gone furthest, with 0 descendants of its own.
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. 2012, 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 IM-11 Pneumatic Microinjector is used for Intracytoplasmic Sperm Injection (ICSI) procedures to aspirate and inject sperm into oocytes, and to hold oocytes during the ICSI procedure.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113712 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113712: IM-11 Pneumatic Microinjector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113712
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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