510(k) · Cleared
ClearedModification to Intracytoplasmic Sperm Injection (Isci), Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes,
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Urological, Inc. · MQH Microtools, Assisted Reproduction (Pipettes)
Cleared on Jan 16, 2004 after a 30-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Jan 16, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- MQH
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK033903 Modification to Intracytoplasmic Sperm Injection (Isci)…Cook Urological, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK151018 Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm…Cook Incorporated · 2016
Most influential descendants
Showing 1 of 1 · See all- K151018Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction PipetteCook Incorporated · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033903 | Modification to Intracytoplasmic Sperm Injection (Isci), Micro-Injection… | Cook Urological, Inc. | 2004 | — |
| +1 | K151018 | Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction… | Cook Incorporated | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (5)
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 |
|---|---|---|---|
| * | — | Intracytoplasmic Micropipet Named without a submission number | |
| * | — | Holding Micropipet Named without a submission number | |
| * | — | Laboratory Micropipette Art. No. 33311 Named without a submission number | |
| * | — | Laboratory Micropipette Art. No. 22218 Named without a submission number | |
| * | — | (ICSI) pipettes, holding pipettes, denuding pipettes and assisted hatching/zona drilling… Named without a submission number |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K151018 | Embryo Biopsy Pipette, Polar Body Biopsy Pipette, Testicular Sperm Extraction Pipette | 2016 | 0 |
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?
- Of its descendants, K151018 (Cook Incorporated, 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MQH devicesMQH Microtools, Assisted Reproduction (Pipettes): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Intracytoplasmic Sperm Injection (ICSI) Micro-Injection Pipettes are used for the intracytoplasmic single sperm injection of oocytes. The Holding Pipettes are used to hold the oocyte in position with the application of vacuum. The Denuding Pipettes are used to remove the cumulus cell layers. The Assisted Hatching/Zona Drilling Pipettes are used to make a hole in the zona pellucida to enable blastomere removal or embryo assisted hatching.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033903 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033903: Modification to Intracytoplasmic Sperm Injection (Isci), Micro-Injection Pipettes, Holding Pipettes, Denuding Pipettes,.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033903
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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