510(k) · Cleared
ClearedFlexipet Denuding Pipette, Flexipet Manipulation 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 Dec 18, 2015 as substantially equivalent to K993699 (Mid-Atlantic Diagnostics, Inc., 2000) after a 270-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Dec 18, 2015
- Review
- 270 days
- Class
- Class II
- Product code
- MQH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993699 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK993699 The StripperMid-Atlantic Diagnostics, Inc. · 2000
- This deviceK150748 Flexipet Denuding Pipette, Flexipet Manipulation PipetteCook Incorporated · 2015
View 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) | K150748 | Flexipet Denuding Pipette, Flexipet Manipulation Pipette | Cook Incorporated | 2015 | — |
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…ct Code: MQH Predicate Device: The predicate device is “THE STRIPPER®” Micropipetter and Micropipetter Tips (Mid-Atlantic Diagnostics, Inc., K993699). K150748 Cook Incor… | 2000 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K993699.
How does its category compare?
All MQH devicesMQH Microtools, Assisted Reproduction (Pipettes): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Flexipet® Denuding Pipettes are intended to be used for blastomere or polar body manipulation, oocyte and embryo manipulation, or denuding.
The Flexipet® Manipulation Pipettes are intended to be used for blastomere or polar body manipulation, oocyte and embryo manipulation, blastocyst handling, and manipulation of the oocyte-cumulus complex.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150748 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150748: Flexipet Denuding Pipette, Flexipet Manipulation Pipette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150748
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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