510(k) · Cleared
ClearedBlastomere Biopsy Pipettes, Polar Body Biopsy Pipettes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunlight Medical, Inc. · MQH Microtools, Assisted Reproduction (Pipettes)
Cleared on Apr 30, 2010 as substantially equivalent to K012811 (Humagen Fertility Diagnostics, Inc., 2002) after a 253-day review. Its family tree reaches back 2 generations to 1999.
- Decided
- Apr 30, 2010
- Review
- 253 days
- Class
- Class II
- Product code
- MQH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K990847 (1999). 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 deviceK092554 Blastomere Biopsy Pipettes, Polar Body Biopsy PipettesSunlight Medical, Inc. · 2010
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) | K092554 | Blastomere Biopsy Pipettes, Polar Body Biopsy Pipettes | Sunlight Medical, Inc. | 2010 | — |
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 |
|---|---|---|---|
| * | K012811 | Blastomere Biopsy Micropipet, Polar Body Micropipet, Models…Summary page 1…Biopsy Pipettes to be manufactured by Sunlight Medical, Inc. are substantially equivalent to the Blastomere Biopsy Micropipets and Polar Body Micropipets (5 10K number: K01281 1) manufactured by Humagen Fertility Diagnostics, Inc., 2345 Hunter's Way, Charlottesville, VA 22901-7928. Specially, the Biopsy Pi… | 2002 |
| † | K072600 | Intracytoplasmic Sperm and Spermatid Injection, Holding, Zone Drilling, Partial Zone… | 2008 |
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 11 years and passes through 2 companies; a new generation was cleared every 8.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K012811.
How does its category compare?
All MQH devicesMQH Microtools, Assisted Reproduction (Pipettes): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Blastomere Biopsy Pipettes are tools used in IVF/Assisted Reproduction Technology (ART) laboratories for removal of blastomere(s) from embryos, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s).
The Polar Body Biopsy Pipettes are tools used in IVF/Assisted Reproduction Technology (ART) laboratories for removal of polar bodies from oocytes, which may be done in order to perform preimplantation genetic diagnosis on the genetic material in the biopsied cell(s).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092554 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092554: Blastomere Biopsy Pipettes, Polar Body 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/K092554
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