510(k) · Cleared
ClearedInjection Pipette; Holding Pipette; Biopsy Pipette; Denuding Pipette; Partial Zona Dissection (PZD) Pipette; Assisted HA
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jieying Laboratory, Inc. · MQH Microtools, Assisted Reproduction (Pipettes)
Cleared on Apr 19, 2011 as substantially equivalent to K990847 (Humagen Fertility Diagnostics, Inc., 1999) and 1 other predicate after a 232-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Apr 19, 2011
- Review
- 232 days
- Class
- Class II
- Product code
- MQH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K990847 (1999). No later device cites it as a predicate yet.
- Root · 2 generations backK990847 Intracytoplasmic Sperm Injection Micropipets (Icsi) Spermatid Icsi…Humagen Fertility Diagnostics, Inc. · 1999 · Recalled
- 1 generation backK012811 Blastomere Biopsy Micropipet, Polar Body Micropipet, Models…Humagen Fertility Diagnostics, Inc. · 2002
- This deviceK102480 Injection Pipette; Holding Pipette; Biopsy Pipette; Denuding…Jieying Laboratory, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K990847 | Intracytoplasmic Sperm Injection Micropipets (Icsi) Spermatid Icsi… | Humagen Fertility Diagnostics, Inc. | 1999 | 1 |
| −1 | K012811 | Blastomere Biopsy Micropipet, Polar Body Micropipet, Models… | Humagen Fertility Diagnostics, Inc. | 2002 | — |
| 0 (this device) | K102480 | Injection Pipette; Holding Pipette; Biopsy Pipette; Denuding Pipette; Partial… | Jieying Laboratory, Inc. | 2011 | — |
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 |
|---|---|---|---|
| * | K990847 | Intracytoplasmic Sperm Injection Micropipets (Icsi) Spermatid Icsi Micropipets, Holding…Summary page 2…Predicate K Applicant Laboratory Device Name Reference Injection pipette Intracytoplasmic K990847 Humagen Fertility Sperm Injection Diagnostics, Inc. M… | 1999 |
| * | K012811 | Blastomere Biopsy Micropipet, Polar Body Micropipet, Models…Summary page 2…Fertility ___________ Diagnostics, Inc. Biopsy pipette Blastomere Biopsy K012811 Humagen Fertility _____________ Micropipet _______ Diagnostics, Inc. Po… | 2002 |
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 12 years and passes through 2 companies; a new generation was cleared every 9.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K990847.
How does its category compare?
All MQH devicesMQH Microtools, Assisted Reproduction (Pipettes): FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Tool used in IVF/Assisted Reproduction Technology (ART) laboratories for intracytoplasmic sperm injection (ICSI). Tool used in IVF/Assisted Reproduction Technology (ART) laboratories for holding oocyte or embryo during ICSI or biopsy. Tool used in IVF/Assisted Reproduction Technology (ART) laboratories for removal of blastomere(s) from embryos, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied…
Read the full statement (177 words)
Tool used in IVF/Assisted Reproduction Technology (ART) laboratories for intracytoplasmic sperm injection (ICSI).
Tool used in IVF/Assisted Reproduction Technology (ART) laboratories for holding oocyte or embryo during ICSI or biopsy.
Tool used in IVF/Assisted Reproduction Technology (ART) laboratories for removal of blastomere(s) from embryos, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s)
Tool used in IVF/Assisted Reproduction Technology (ART) laboratories for removal of polar bodies from oocytes, which may be done in order to perform pre implantation genetic diagnosis on the genetic material in the biopsied cell(s).
Tool used in IVF/Assisted Reproduction Technology (ART) laboratories to denuding cumulus cells from oocytes by delivering enzymes to aid separation
Tool used in IVF/Assisted Reproduction Technology (ART) laboratories to cut zona pellucida to create a defect in the zona pellucida mechanically in order to perform assisted hatching of embryos mechanically.
Tool used in IVF/Assisted Reproduction Technology (ART) laboratories to create a defect in the zona pellucida chemically using Tyrode's acid solution in order to perform assisted hatching of embryos.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102480 · printed Nov 3, 2026
Cite this page
510(k) Report. “K102480: Injection Pipette; Holding Pipette; Biopsy Pipette; Denuding Pipette; Partial Zona Dissection (PZD) Pipette; Assisted HA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K102480
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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