510(k) · Cleared
ClearedBlastomere Biopsy Pipette, Models H-55530 and H-55540
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Swemed Lab International AB · MQH Microtools, Assisted Reproduction (Pipettes)
Cleared on Nov 5, 2002 after an 89-day review. The FDA summary names its predicate without a number.
- Decided
- Nov 5, 2002
- Review
- 89 days
- Class
- Class II
- Product code
- MQH
- Recalls
- None
- Predicates
- 0
The FDA summary names its predicate without a number.
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? (3)
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 |
|---|---|---|---|
| * | — | Assisted Hatching/Zona Drilling Pipette component of Swemed's Follicle Aspiration Set Named without a submission number | |
| * | — | Cook OB/GYN's Pre-Implantation Genetic Diagnosis Pipette Named without a submission number | |
| * | — | Humagen Fertility Diagnostics, Inc.'s Blastomere Biopsy Micropipette Named without a submission number |
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.
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 Swemed Blastomere Biopsy Pipette is intended to conduct a blastomere biopsy, which may be done in order to perform pre-implantation genetic diagnosis on the genetic material in the biopsied cell(s). The Swemed Blastomere Biopsy Pipette is indicated to aspirate blastomeres containing genetic material for the purpose of pre-implantation genetic diagnosis. This tool is indicated for embryo or blastomere biopsy, which may be done in order to perform…
Read the full statement (130 words)
The Swemed Blastomere Biopsy Pipette is intended to conduct a blastomere biopsy, which may be done in order to perform pre-implantation genetic diagnosis on the genetic material in the biopsied cell(s).
The Swemed Blastomere Biopsy Pipette is indicated to aspirate blastomeres containing genetic material for the purpose of pre-implantation genetic diagnosis.
This tool is indicated for embryo or blastomere biopsy, which may be done in order to perform preimplantation genetic diagnosis (PIGD) on the genetic material in the biopsied cell(s). Tests for PGD are currently developed and their performance characteristics are determined by the individual laboratories for their own use. The performance of these tests may vary depending on the particular assay and disease evaluated. Currently these tests have not been cleared or approved by the Food and Drug Administration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022643 · printed Nov 6, 2026
Cite this page
510(k) Report. “K022643: Blastomere Biopsy Pipette, Models H-55530 and H-55540.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022643
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026