510(k) · Cleared
ClearedRevogene
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Bioscience, Inc. · OOI Real Time Nucleic Acid Amplification System
Cleared on Jul 11, 2022 as substantially equivalent to K170558 (Genepoc, Inc., 2017) after a 143-day review. Its family tree reaches back 1 generation to 2017. 2 later devices descend from it.
- Decided
- Jul 11, 2022
- Review
- 143 days
- Class
- Class II
- Product code
- OOI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K170558 (2017). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK170558 revogeneGenepoc, Inc. · 2017 · Recalled
- This deviceK220480 RevogeneMeridian Bioscience, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK222779 RevogeneMeridian Bioscience, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK243922 RevogeneMeridian Bioscience, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K170558 | revogene | Genepoc, Inc. | 2017 | 2 |
| 0 (this device) | K220480 | Revogene | Meridian Bioscience, Inc. | 2022 | — |
| +1 | K222779 | Revogene | Meridian Bioscience, Inc. | 2023 | — |
| +2 | K243922 | Revogene | Meridian Bioscience, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 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 OOI? 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 OOI device
- #1 K243922 Revogenescore 9.6 · 3 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 |
|---|---|---|---|
| * | K170558 | revogeneSummary page 5…MOCK PIE (use if less than 8 samples processed in a single run) Requirements: F. Device Modification Description The Revogene was previously cleared under K170558. Meridian Biosciences, Inc. is submitting this 510(k) to implement a software modification to the Revogene that updates the curre… | 2017 |
| † | K170557 | GenePOC GBS LB | 2017 |
| † | K172569 | GenePOC CDiff | 2017 |
| † | K183366 | GenePOC Strep A | 2019 |
| † | K190275 | GenePOC Carba | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222779 | Revogene | 2023 | 1 |
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?
- Its one ancestor has a recall.
- Of its descendants, K222779 (Meridian Bioscience, Inc., 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All OOI devicesOOI Real Time Nucleic Acid Amplification System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · OOI
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OOI
249in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OOI
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OOI
524in 2025
MAUDE reports naming product code OOI, 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 | 3 | 249 | 1 | 0 |
| 2011 | 0 | — | 2 | 5 |
| 2012 | 1 | — | 0 | 3 |
| 2013 | 1 | — | 1 | 1 |
| 2014 | 1 | — | 0 | 5 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 3 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 134 |
| 2021 | 0 | — | 4 | 324 |
| 2022 | 1 | — | 4 | 874 |
| 2023 | 1 | — | 1 | 220 |
| 2024 | 0 | — | 1 | 327 |
| 2025 | 1 | — | 0 | 524 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Revogene@ instrument is intended for in vitro diagnostic (IVD) use in performing nucleic acid testing of specific IVD assays in clinical laboratories. Revogene is capable of automated lysis and dilution of samples originating from various clinical specimen types. Revogene performs automated amplification and detection of target nucleic acid sequences by fluorescence-based real-time PCR.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220480 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220480: Revogene.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220480
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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