510(k) · Cleared
Recalled · Class II · 2019Intracytoplasmic Sperm Injection Micropipets (Icsi) Spermatid Icsi Micropipets, Holding Micropipets, Assisted Hatching M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Humagen Fertility Diagnostics, Inc. · MQH Microtools, Assisted Reproduction (Pipettes)
Cleared on Jul 14, 1999 after a 121-day review. The FDA summary names no predicate by number. 5 later devices descend from it. It has been recalled once.
- Decided
- Jul 14, 1999
- Review
- 121 days
- Class
- Class II
- Product code
- MQH
- Recalls
- 1
- Predicates
- 0
5 later devices descend from it, 3 citing it directly.
- This deviceK990847 Intracytoplasmic Sperm Injection Micropipets (Icsi) Spermatid Icsi…Humagen Fertility Diagnostics, Inc. · 1999
- Descendant · cites it directly · 3 of its ownK012811 Blastomere Biopsy Micropipet, Polar Body Micropipet, Models…Humagen Fertility Diagnostics, Inc. · 2002
- Descendant · 2 generations on · 0 of its ownK133257 Biopsy PipettesResearch Instruments, Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK102480 Injection Pipette; Holding Pipette; Biopsy Pipette; Denuding…Jieying Laboratory, Inc. · 2011
- Descendant · 2 generations on · 0 of its ownK092554 Blastomere Biopsy Pipettes, Polar Body Biopsy PipettesSunlight Medical, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK024302 Precision Capillaries for MicromanipulationBrinkmann Instruments, Inc. · 2003
Most influential descendants
Showing 5 of 5 · See all- K012811Blastomere Biopsy Micropipet, Polar Body Micropipet, Models…Humagen Fertility Diagnostics, Inc. · 2002 · cites it directly3descendants
- K133257Biopsy PipettesResearch Instruments, Ltd. · 2014 · 2 generations on0descendants
- K102480Injection Pipette; Holding Pipette; Biopsy Pipette; Denuding Pipette; Partial Zona…Jieying Laboratory, Inc. · 2011 · cites it directly0descendants
- K092554Blastomere Biopsy Pipettes, Polar Body Biopsy PipettesSunlight Medical, Inc. · 2010 · 2 generations on0descendants
- K024302Precision Capillaries for MicromanipulationBrinkmann Instruments, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K990847 | Intracytoplasmic Sperm Injection Micropipets (Icsi) Spermatid Icsi… | Humagen Fertility Diagnostics, Inc. | 1999 | — |
| +1 | K012811 | Blastomere Biopsy Micropipet, Polar Body Micropipet, Models… | Humagen Fertility Diagnostics, Inc. | 2002 | — |
| +2 | K133257 | Biopsy Pipettes | Research Instruments, Ltd. | 2014 | — |
| +1 | K102480 | Injection Pipette; Holding Pipette; Biopsy Pipette; Denuding Pipette; Partial… | Jieying Laboratory, Inc. | 2011 | — |
| +2 | K092554 | Blastomere Biopsy Pipettes, Polar Body Biopsy Pipettes | Sunlight Medical, Inc. | 2010 | — |
| +1 | K024302 | Precision Capillaries for Micromanipulation | Brinkmann Instruments, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 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 MQH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MQH device
- #1 K250838 Denudation Pipettesscore 9.9 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 27, 2019 | Class II | Z-1367-2019 | Under Investigation by firm | ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K012811 (Humagen Fertility Diagnostics, Inc., 2002) has gone furthest, with 3 descendants of its own.
How does its category compare?
All MQH devicesMQH Microtools, Assisted Reproduction (Pipettes): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQH
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQH
Too few MQH 510(k)s in any year since 2007 to give a median.
Recalls per year · MQH
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQH
10in 2021
MAUDE reports naming product code MQH, 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 | — | 1 | 0 |
| 2008 | 1 | — | 2 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 6 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 1 | — | 0 | 1 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 10 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The micropipet family's indication for use is to manipulate zygotes during the ICSI procedure.
Micropipets are used in the tissue culture techniques performed by embryologists when injecting a single sperm into an egg, or assisting an embryo in hatching prior to re-implantation.
The micropipets are tools used in procedures that have been developed to aid infertile couples achieve pregnancy. Specifically, the ICSI procedure is beneficial in cases where the male fertility is impaired.
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/K990847 · printed Nov 6, 2026
Cite this page
510(k) Report. “K990847: Intracytoplasmic Sperm Injection Micropipets (Icsi) Spermatid Icsi Micropipets, Holding Micropipets, Assisted Hatching M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K990847
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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