510(k) · Cleared
ClearedEmbryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Incorporated · MQH Microtools, Assisted Reproduction (Pipettes)
Cleared on Jan 8, 2016 as substantially equivalent to K033904 (Cook Urological, Inc., 2004) and 1 other predicate after a 267-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Jan 8, 2016
- Review
- 267 days
- Class
- Class II
- Product code
- MQH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K033904 (2004). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK033904 Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes)Cook Urological, Inc. · 2004
- This deviceK151018 Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm…Cook Incorporated · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033904 | Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes) | Cook Urological, Inc. | 2004 | — |
| 0 (this device) | K151018 | Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction… | Cook Incorporated | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 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? (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 |
|---|---|---|---|
| * | K033904 | Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes)Summary page 5…ices: The predicate device for the Embryo Biopsy and the Polar Body Biopsy is as follows: Cook’s Pre-Implantation Genetic Diagnosis Pipettes (Biopsy Pipettes) (K033904) The predicate device for the Sperm Extraction Pipettes is as follows: Cook’s Intracytoplasmic Sperm Injection (ICSI),… | 2004 |
| * | K033903 | Modification to Intracytoplasmic Sperm Injection (Isci), Micro-Injection Pipettes…Summary page 5… Cook’s Intracytoplasmic Sperm Injection (ICSI), Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes, and Assisted Hatching/Zona Drilling Pipettes (K033903) Device Description: The Embryo Biopsy, Polar Body Biopsy, and Testicular Sperm Extraction Pipettes are 970 microns (µm) outer… | 2004 |
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?
- None of the 2 ancestors has a recall.
How does its category compare?
All MQH devicesMQH Microtools, Assisted Reproduction (Pipettes): FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
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 Embryo Biopsy Pipette is intended to aspirate a blastomere or trophectoderm to diagnose genetic disorders prior to embryo selection.
The Polar Body Biopsy Pipette is intended to aspirate polar bodies to diagnose genetic disorders prior to embryo selection.
The Testicular Sperm Extraction Pipette is intended to extract sperm cells from biopsied testicular tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151018 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151018: Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151018
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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