510(k) · Cleared
ClearedBiopsy Pipettes
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 May 16, 2014 as substantially equivalent to K991261 (Research Instruments, Ltd., 1999) and 1 other predicate after a 205-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- May 16, 2014
- Review
- 205 days
- Class
- Class II
- Product code
- MQH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K990847 (1999). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK990847 Intracytoplasmic Sperm Injection Micropipets (Icsi) Spermatid Icsi…Humagen Fertility Diagnostics, Inc. · 1999 · Recalled
- 1 generation backK012811 Blastomere Biopsy Micropipet, Polar Body Micropipet, Models…Humagen Fertility Diagnostics, Inc. · 2002
- This deviceK133257 Biopsy PipettesResearch Instruments, Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K990847 | Intracytoplasmic Sperm Injection Micropipets (Icsi) Spermatid Icsi… | Humagen Fertility Diagnostics, Inc. | 1999 | 1 |
| −1 | K012811 | Blastomere Biopsy Micropipet, Polar Body Micropipet, Models… | Humagen Fertility Diagnostics, Inc. | 2002 | — |
| 0 (this device) | K133257 | Biopsy Pipettes | Research Instruments, Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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? (2)
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 |
|---|---|---|---|
| * | K991261 | Icsi Injection Micropipette (Spiked & Non-Spiked), Icsi Holding Miceopipette, Assisted…Summary page 1…, Holding, Assisted Hatching, Denuding Manufacturer: Research Instruments Ltd Classification Name: Microtools, Assisted Reproduction 510O(K): K991261 Regulation Number: 21CFR 844.6130 Product Code: MQH Predicate 2 Trade Name: Polar body biopsy microp… | 1999 |
| * | K012811 | Blastomere Biopsy Micropipet, Polar Body Micropipet, Models…Summary page 1…blastomere biopsy micropipet Manufacturer: Humagen Fertility Diagnostics, Inc Classification Name: Microtools, Assisted Reproduction 510(K): K012811 Regulation Number: 21CFR 884.6130 Product Code: MQH… | 2002 |
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 15 years and passes through 2 companies; a new generation was cleared every 12.3 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All MQH devicesMQH Microtools, Assisted Reproduction (Pipettes): FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
Biopsy pipettes are used in assisted reproduction techniques (ART) for the removal of blastomere(s) from embryos or polar bodies from oocytes, which may be done in order to perform preimplantation genetic diagnosis (PGD) on the genetic materials in the biopsied cell(s).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133257 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133257: Biopsy Pipettes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133257
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