510(k) · Cleared
ClearedMUTYH-Associated Polyposis (MAP)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
23AndMe, Inc. · QAZ Cancer Predisposition Risk Assessment System
Cleared on Jan 18, 2019 as substantially equivalent to DEN170046 (23AndMe, Inc., 2018) after a 109-day review. Its family tree reaches back 1 generation to 2018. 1 later device descends from it.
- Decided
- Jan 18, 2019
- Review
- 109 days
- Class
- Class II
- Product code
- QAZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN170046 (2018). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backDEN170046 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected…23AndMe, Inc. · 2018
- This deviceK182784 MUTYH-Associated Polyposis (MAP)23AndMe, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK211499 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer…23AndMe, Inc. · 2022
Most influential descendants
Showing 1 of 1 · See all- K21149923andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related)23AndMe, Inc. · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN170046 | 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) | 23AndMe, Inc. | 2018 | — |
| 0 (this device) | K182784 | MUTYH-Associated Polyposis (MAP) | 23AndMe, Inc. | 2019 | — |
| +1 | K211499 | 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) | 23AndMe, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 QAZ? 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 QAZ device
- #1 K223597 23andMe® Personal Genome Service® (PGS®)…score 5.9 · 1 generation · 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 |
|---|---|---|---|
| * | DEN170046 | 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants)Summary page 5…Class II Predicate 23andMe PGS Genetic Health Risk Report for BRCA1/BRCA2 (Selected Device: Variants) authorized on March 6, 2018 under DEN170046 5.2 Intended Use The 23andMe Personal Genome Service (PGS) uses qualitative genotyping to detect select clinically relevant var… | 2018 |
| † | DEN140044 | 23ANDME Personal Genome Service (Hereinafter Known as PGS) | 2015 |
| † | DEN160026 | Genetic Variant Detection And Health Risk Assessment System | |
| † | K141410 | Oragene DX Ogd-500.001 | 2015 |
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 |
|---|---|---|---|
| K211499 | 23andMe PGS Genetic Risk Report for Hereditary Prostate Cancer (HOXB13-Related) | 2022 | 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?
How does its category compare?
All QAZ devicesQAZ Cancer Predisposition Risk Assessment System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · QAZ
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · QAZ
Too few QAZ 510(k)s in any year since 2007 to give a median.
Recalls per year · QAZ
No recall names QAZ since 2007.
Adverse event reports per year · QAZ
1in 2024
MAUDE reports naming product code QAZ, 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 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 1 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The 23andMe Personal Genome Service (PGS) uses qualitative genotyping to detect select clinically relevant variants in genomic DNA isolated from human saliva collected from individuals >18 years with the Oragene Dx model OGD500.001 for the purpose of reporting and interpreting genetic health risks, including the 23andMe PGS Genetic Health Risk Report for MUTYH-Associated Polyposis. The 23andMe PGS Genetic Health Risk Report for MUTYH-Associated Polyposis…
Read the full statement (191 words)
The 23andMe Personal Genome Service (PGS) uses qualitative genotyping to detect select clinically relevant variants in genomic DNA isolated from human saliva collected from individuals >18 years with the Oragene Dx model OGD500.001 for the purpose of reporting and interpreting genetic health risks, including the 23andMe PGS Genetic Health Risk Report for MUTYH-Associated Polyposis. The 23andMe PGS Genetic Health Risk Report for MUTYH-Associated Polyposis is indicated for reporting of the Y179C and the G396D variants in the MUTYH gene. The report describes if a person is at increased risk of developing colorectal cancer. The two variants included in this report are most common and best studied in people of Northern European descent and may not represent the majority of the MUTYH variants found in people of other ethnicities. The test report does not describe a person's overall risk of developing any type of cancer, and the absence of a variant tested does not rule out the presence of other variants that may be cancer-related. This test is not a substitute for visits to a healthcare provider for recommended screenings or appropriate follow-up and should not be used to determine any treatments.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182784 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182784: MUTYH-Associated Polyposis (MAP).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182784
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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