510(k) · Cleared
ClearedDenudation Pipettes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangzhou Pinzhi Medical Device Co., Ltd. · MQH Microtools, Assisted Reproduction (Pipettes)
Cleared on Jul 3, 2025 as substantially equivalent to K161275 (Research Instruments Limited, 2017) after a 105-day review. Its family tree reaches back 2 generations to 2000.
- Decided
- Jul 3, 2025
- Review
- 105 days
- Class
- Class II
- Product code
- MQH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K993699 (2000). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 K192146 V-Denupetscore -0.9 · 2 generations · no Class I recall
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 |
|---|---|---|---|
| * | K161275 | EZ-Tip Singles, EZ-Tip Vial of 20, EZ-GripSummary page 5…dicate Device Research Instruments Ltd. EZ-Tip Vial of 20 K161275 The predicate device has not been subject to a… | 2017 |
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 25 years and passes through 3 companies; a new generation was cleared every 16.7 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K161275.
How does its category compare?
All MQH devicesMQH Microtools, Assisted Reproduction (Pipettes): FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Denudation Pipettes are used for the removal of cumulus oocyte complexes (COC) from an oocyte prior to Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilization (IVF) as well as for the handling of gametes, embryos and biopsied cells (polar bodies, blastomeres and trophectoderm) during assisted reproductive techniques (ART). Denudation Pipettes are not intended for biopsy of cells from oocytes or embryos.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250838 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250838: Denudation Pipettes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250838
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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