510(k) · Cleared
ClearedEZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Research Instruments Limited · MQH Microtools, Assisted Reproduction (Pipettes)
Cleared on Jan 23, 2017 as substantially equivalent to K993699 (Mid-Atlantic Diagnostics, Inc., 2000) after a 262-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Jan 23, 2017
- Review
- 262 days
- Class
- Class II
- Product code
- MQH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993699 (2000). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK993699 The StripperMid-Atlantic Diagnostics, Inc. · 2000
- This deviceK161275 EZ-Tip Singles, EZ-Tip Vial of 20, EZ-GripResearch Instruments Limited · 2017
- Descendant · cites it directly · 0 of its ownK250838 Denudation PipettesGuangzhou Pinzhi Medical Device Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK192146 V-DenupetVitromed GmbH · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993699 | The Stripper | Mid-Atlantic Diagnostics, Inc. | 2000 | — |
| 0 (this device) | K161275 | EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip | Research Instruments Limited | 2017 | — |
| +1 | K250838 | Denudation Pipettes | Guangzhou Pinzhi Medical Device Co., Ltd. | 2025 | — |
| +1 | K192146 | V-Denupet | Vitromed GmbH | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K993699 | The StripperSummary page 4…cturer: Mid-Atlantic Diagnostics, Inc Classification Name: Microtools, Assisted Reproduction (21CFR 884.6130, 85 MQH) 510(K) K993699 The Stripper micopipet and micropipeter tips have not been subject to a design-related recall.… | 2000 |
What descends from it? (2)
2 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. 2017, 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?
EZ-Tip pipettes are for denudation, i.e. removing the cumulus from an oocyte prior to Intracytoplasmic Sperm Injection (ICSI) and In Vitro Fertilization (IVF) and for handling gametes, embryos and biopsied cells (polar bodies, blastomeres and trophectoderm) during assisted reproductive techniques (ART). EZ-Tips are not intended for biopsy of cells from oocytes or embryos.
The EZ-Grip provides aspiration and expulsion capabilities to plastic pipettes when fitted during assisted reproduction procedures.
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/K161275 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161275: EZ-Tip Singles, EZ-Tip Vial of 20, EZ-Grip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161275
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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