510(k) · Cleared
ClearedOragene-DX Ogd-500; Oragene-DX Ogd-575; Oragene-DX Oxd-525; Oragene-DX Oyd-500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
DNA Genotek, Inc. · OYJ Dna Specimen Collection, Saliva
Cleared on Dec 2, 2011 as substantially equivalent to K972075 (Becton Dickinson Vacutainer Systems, 1998) after a 263-day review. Its family tree reaches back 2 generations to 1995. 6 later devices descend from it.
- Decided
- Dec 2, 2011
- Review
- 263 days
- Class
- Class II
- Product code
- OYJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K945952 (1995). 3 ancestors in all. 6 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK945952 Vacutainer (R) Brand Plus PST (TM) Plasma Separation TubeBd Becton Dickinson Vacutainer Systems Preanalytic · 1995 · Recalled
- 1 generation backK972075 Vacutainer Brand PPT Plasma Preparation TubeBecton Dickinson Vacutainer Systems · 1998
- This deviceK110701 Oragene-DX Ogd-500; Oragene-DX Ogd-575; Oragene-DX Oxd-525…DNA Genotek, Inc. · 2011
- Descendant · cites it directly · 3 of its ownK141410 Oragene DX Ogd-500.001DNA Genotek, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK152556 Oragene DxDNA Genotek, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK192920 Oragene®•DxDNA Genotek, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK212745 ORAcollect®•DxDNA Genotek, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK192947 AncestryDNA Saliva Collection KitAncestry Genomics, Inc. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K141410Oragene DX Ogd-500.001DNA Genotek, Inc. · 2015 · cites it directly3descendants
- K152556Oragene DxDNA Genotek, Inc. · 2016 · cites it directly2descendants
- K192920Oragene®•DxDNA Genotek, Inc. · 2020 · cites it directly1descendant
- K212745ORAcollect®•DxDNA Genotek, Inc. · 2022 · 2 generations on0descendants
- K192947AncestryDNA Saliva Collection KitAncestry Genomics, Inc. · 2020 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K945952 | Vacutainer (R) Brand Plus PST (TM) Plasma Separation Tube | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995 | 10 |
| −1 | K972075 | Vacutainer Brand PPT Plasma Preparation Tube | Becton Dickinson Vacutainer Systems | 1998 | — |
| 0 (this device) | K110701 | Oragene-DX Ogd-500; Oragene-DX Ogd-575; Oragene-DX Oxd-525; Oragene-DX Oyd-500 | DNA Genotek, Inc. | 2011 | — |
| +1 | K141410 | Oragene DX Ogd-500.001 | DNA Genotek, Inc. | 2015 | — |
| +1 | K152556 | Oragene Dx | DNA Genotek, Inc. | 2016 | — |
| +1 | K192920 | Oragene®•Dx | DNA Genotek, Inc. | 2020 | — |
| +2 | K212745 | ORAcollect®•Dx | DNA Genotek, Inc. | 2022 | — |
| +2 | K192947 | AncestryDNA Saliva Collection Kit | Ancestry Genomics, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2020 | 2 | 0 |
| 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 OYJ? 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 OYJ device
- #1 K212745 ORAcollect®•Dxscore 5.4 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 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 |
|---|---|---|---|
| * | K972075 | Vacutainer Brand PPT Plasma Preparation TubeSummary page 1…n: Class 11 Product Code: OYJ DNA Specimen Collection, Saliva Predicate Device VacutainerO Brand PPV~m Plasma Preparation Tube (k972075) DEVICE DESCRIPTION The Oragene-Dx family of products offers reliable collection, stabilization, transportation and long-term r… | 1998 |
What descends from it? (6)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 16 years and passes through 3 companies; a new generation was cleared every 13.8 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K141410 (DNA Genotek, Inc., 2015) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K972075.
How does its category compare?
All OYJ devicesOYJ Dna Specimen Collection, Saliva: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · OYJ
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · OYJ
Too few OYJ 510(k)s in any year since 2007 to give a median.
Recalls per year · OYJ
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OYJ
4in 2022
MAUDE reports naming product code OYJ, 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 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 2 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 1 | — | 1 | 4 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Oragene.Dx is intended for use in the non-invasive collection of saliva samples. DNA from the saliva sample is isolated, stabilized, and suitable for use in FDA cleared molecular diagnostic applications. Saliva may be collected by spitting directly into the Oragene-Dx container or may be transferred into the Oragene-Dx container using a sponge. Saliva samples collected using OrageneDx are stabilized and can be transported and/or stored long term at ambient conditions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110701 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110701: Oragene-DX Ogd-500; Oragene-DX Ogd-575; Oragene-DX Oxd-525; Oragene-DX Oyd-500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110701
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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