510(k) · Cleared
Recalled · Class II · 2022revogene
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genepoc, Inc. · OOI Real Time Nucleic Acid Amplification System
Cleared on May 25, 2017 after a 90-day review. The FDA summary names no predicate by number. 3 later devices descend from it. It has been recalled 2 times.
- Decided
- May 25, 2017
- Review
- 90 days
- Class
- Class II
- Product code
- OOI
- Recalls
- 2
- Predicates
- 0
3 later devices descend from it, 1 citing it directly.
- This deviceK170558 revogeneGenepoc, Inc. · 2017
- Descendant · cites it directly · 2 of its ownK220480 RevogeneMeridian Bioscience, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK222779 RevogeneMeridian Bioscience, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK243922 RevogeneMeridian Bioscience, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K170558 | revogene | Genepoc, Inc. | 2017 | — |
| +1 | K220480 | Revogene | Meridian Bioscience, Inc. | 2022 | — |
| +2 | K222779 | Revogene | Meridian Bioscience, Inc. | 2023 | — |
| +3 | K243922 | Revogene | Meridian Bioscience, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 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
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K220480 | Revogene | 2022 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 22, 2022 | Class II | Z-1479-2022 | Device Design | When a run is aborted, the cooling period protection does not occur and the user is able to open the lid prior to the completion of the cooling period, exposing the user to heated instrument components. Incidental contact with heated… |
| Feb 15, 2022 | Class II | Z-0836-2022 | Component design/selection | The photomultiplier tube, may have compromised functionality in some instruments. As a result, the user is likely to observe an increase in false-positive or indeterminate results. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K220480 (Meridian Bioscience, Inc., 2022) has gone furthest, with 2 descendants 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. 2017, 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. The 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/K170558 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170558: revogene.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170558
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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