510(k) · Cleared
ClearedBlastomere Biopsy Micropipet, Polar Body Micropipet, Models 10-MBB,10-MBB-B,10-MPB,10-MPB-B
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 Feb 11, 2002 as substantially equivalent to K990847 (Humagen Fertility Diagnostics, Inc., 1999) after a 173-day review. Its family tree reaches back 1 generation to 1999. 3 later devices descend from it.
- Decided
- Feb 11, 2002
- Review
- 173 days
- Class
- Class II
- Product code
- MQH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K990847 (1999). 3 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK990847 Intracytoplasmic Sperm Injection Micropipets (Icsi) Spermatid Icsi…Humagen Fertility Diagnostics, Inc. · 1999 · Recalled
- This deviceK012811 Blastomere Biopsy Micropipet, Polar Body Micropipet, Models…Humagen Fertility Diagnostics, Inc. · 2002
- Descendant · cites it directly · 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 · cites it directly · 0 of its ownK092554 Blastomere Biopsy Pipettes, Polar Body Biopsy PipettesSunlight Medical, Inc. · 2010
Most influential descendants
Showing 3 of 3 · See all- K133257Biopsy PipettesResearch Instruments, Ltd. · 2014 · cites it directly0descendants
- 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 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990847 | Intracytoplasmic Sperm Injection Micropipets (Icsi) Spermatid Icsi… | Humagen Fertility Diagnostics, Inc. | 1999 | 1 |
| 0 (this device) | K012811 | Blastomere Biopsy Micropipet, Polar Body Micropipet, Models… | Humagen Fertility Diagnostics, Inc. | 2002 | — |
| +1 | K133257 | Biopsy Pipettes | Research Instruments, Ltd. | 2014 | — |
| +1 | K102480 | Injection Pipette; Holding Pipette; Biopsy Pipette; Denuding Pipette; Partial… | Jieying Laboratory, Inc. | 2011 | — |
| +1 | K092554 | Blastomere Biopsy Pipettes, Polar Body Biopsy Pipettes | Sunlight Medical, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K990847 | Intracytoplasmic Sperm Injection Micropipets (Icsi) Spermatid Icsi Micropipets, Holding…Summary page 1…dy Biopsy Micropipet Substantial Equivalence: The biopsy micropipets submitted for approval are similar to other micropipets manufactured by Humagen and approved under K990847. It is the understanding of Humagen that the usage of the micropipets differs from those approved under the previous 510K submiss… | 1999 |
What descends from it? (3)
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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
Biopsy micropipets are used to aspirate polar bodies or blastomeres containing genetic material for the purpose or pre-implantation genetic diagnosis. These devices are intended for single use and will be supplied sterile. The labeling will contain the following statement, in prominent and boxed format: “This tool is indicated for embryo or blastomere biopsy, which may be done in order to perform preimplantation genetic diagnosis (PGD) on the genetic…
Read the full statement (122 words)
Biopsy micropipets are used to aspirate polar bodies or blastomeres containing genetic
material for the purpose or pre-implantation genetic diagnosis. These devices are
intended for single use and will be supplied sterile. The labeling will contain the
following statement, in prominent and boxed format:
“This tool is indicated for embryo or blastomere biopsy, which may be done in order
to perform preimplantation genetic diagnosis (PGD) on the genetic material in the
biopsied cell(s). Tests for PGD are currently developed and their petformance
characteristics are determined by individual laboratories for their own use. The
performance of these tests may vary depending on the particular assay and disease
evaluated. Currently these tests have not been cleared or approved by the Food and
Drug Administration.”
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/K012811 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012811: Blastomere Biopsy Micropipet, Polar Body Micropipet, Models 10-MBB,10-MBB-B,10-MPB,10-MPB-B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012811
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026