510(k) · Cleared
ClearedIcsi Injection Micropipette (Spiked & Non-Spiked), Icsi Holding Miceopipette, Assisted Hatching/Zona Drilling Micropipet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Research Instruments, Ltd. · MQH Microtools, Assisted Reproduction (Pipettes)
Cleared on Aug 5, 1999 after a 114-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- Aug 5, 1999
- Review
- 114 days
- Class
- Class II
- Product code
- MQH
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK991261 Icsi Injection Micropipette (Spiked & Non-Spiked), Icsi Holding…Research Instruments, Ltd. · 1999
- Descendant · cites it directly · 0 of its ownK133257 Biopsy PipettesResearch Instruments, Ltd. · 2014
Most influential descendants
Showing 1 of 1 · See all- K133257Biopsy PipettesResearch Instruments, Ltd. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991261 | Icsi Injection Micropipette (Spiked & Non-Spiked), Icsi Holding Miceopipette… | Research Instruments, Ltd. | 1999 | — |
| +1 | K133257 | Biopsy Pipettes | Research Instruments, Ltd. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K133257 | Biopsy Pipettes | 2014 | 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, K133257 (Research Instruments, Ltd., 2014) 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?
ICSI injection micropipettes are used for injecting spermatozoa into the cytoplasm of an oocyte during intracytoplasmic sperm injection (ICSI).
Holding micropipettes are used to anchor the oocyte under vacuum during intracytoplasmic sperm injection (ICSI).
Assisted hatching micropipettes are used to direct Tyrode’s solution onto the zona of an oocyte, thus creating a hole and enabling the oocyte to hatch.
Denuding pipettes are used to strip the cumulus from oocytes prior to intracytoplasmic sperm injection (ICSI).
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991261: Icsi Injection Micropipette (Spiked & Non-Spiked), Icsi Holding Miceopipette, Assisted Hatching/Zona Drilling Micropipet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991261
Report an extraction error
Are you the manufacturer?
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