510(k) · Cleared
Recalled · Class II · 2014Abbott M2000SP and Abbott M2000RT, Models 9K14-01 (G-Series), 9K14-02 (E-Series), 9K1501
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Abbott Molecular, Inc. · OOI Real Time Nucleic Acid Amplification System
Cleared on May 28, 2010 as substantially equivalent to K012966 (Roche Molecular Systems, Inc., 2002) after a 267-day review. Its family tree reaches back 3 generations to 1993. 2 later devices descend from it. It has been recalled 7 times.
- Decided
- May 28, 2010
- Review
- 267 days
- Class
- Class II
- Product code
- OOI
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 3 generations to K922906 (1993). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK922906 Amplicor Chlamydia Trachomatis TestRoche Molecular Systems, Inc. · 1993
- 2 generations backK964506 Roche Cobas Amplicor AnalyzerRoche Molecular Systems, Inc. · 1997 · Recalled
- 1 generation backK012966 Roche Cobas Taqman AnalyzerRoche Molecular Systems, Inc. · 2002 · Recalled
- This deviceK092705 Abbott M2000SP and Abbott M2000RT, Models 9K14-01 (G-Series)…Abbott Molecular, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK123955 Quantstudio DX Real-Time PCR InstrumentLife Technologies Corporation · 2013
- Descendant · cites it directly · 0 of its ownK113319 Rotor-Gene Q MDXQIAGEN GmbH · 2012 · Recalled
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 |
|---|---|---|---|---|---|
| −3 | K922906 | Amplicor Chlamydia Trachomatis Test | Roche Molecular Systems, Inc. | 1993 | — |
| −2 | K964506 | Roche Cobas Amplicor Analyzer | Roche Molecular Systems, Inc. | 1997 | 1 |
| −1 | K012966 | Roche Cobas Taqman Analyzer | Roche Molecular Systems, Inc. | 2002 | 3 |
| 0 (this device) | K092705 | Abbott M2000SP and Abbott M2000RT, Models 9K14-01 (G-Series), 9K14-02… | Abbott Molecular, Inc. | 2010 | — |
| +1 | K123955 | Quantstudio DX Real-Time PCR Instrument | Life Technologies Corporation | 2013 | — |
| +1 | K113319 | Rotor-Gene Q MDX | QIAGEN GmbH | 2012 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K012966 | Roche Cobas Taqman AnalyzerSummary page 4…2 I CFR §862.2570 (Class II, Procode 001). 5.0 Predicate Devices Roche COBAS® TaqMan® Analyzer (K012966) 6.0 Device Description The Abbott m2000 System is an instrument platform that automates steps to perform nuc… | 2002 |
What descends from it? (2)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 23, 2014 | Class II | Z-0463-2015 | Software design (manufacturing process) | Some versions of Application Specifications (App Spec) are incompatible with m2000sp system software version 6.0 and 7.0. This issue will cause Error Code 9000 (An unexpected error has occurred: Software error) to be generated when the… |
| Jun 19, 2014 | Class II | Z-2169-2014 | Employee error | Abbott Molecular identified that some of the 5 ml Reaction Vessels (RVs) contained in lots 56944001, 57026001, 57059001, and 57673001 (original vendor lot 2198077) may have an insufficient rim. An RV with an insufficient rim may not be… |
| Nov 23, 2013 | Class II | Z-0948-2015 | Nonconforming Material/Component | The x-drive assembly may fail prematurely. This could cause the manipulator or liquid handling arm to contact an object, shake and drip, or improperly pipet. |
| Dec 4, 2012 | Class II | Z-0634-2013 | Software design | An issue with the m2000sp Instrument software has been identified whereby, after a series of steps, if changes are made to the control or calibrator information on the Sample Extraction Assay Details screen, the changes are not saved. |
| Jan 31, 2012 | Class II | Z-2013-2012 | Error in labeling | In the Abbott Molecular Bar Code Scanner User's Guide, List Number 6L88-02/09, the section Modifying the Keyboard Format for Bar Code Scanner LN 6L89-01 contains incorrect bar codes that can prevent the correct configuration of the bar… |
| Oct 11, 2011 | Not classified | Z-0365-2012 | Component design/selection | Abbott Molecular has received reports in which the liquid waste sensor and components in the m2000sp lower instrument cabinet overheated and/or caught fire. |
| Sep 8, 2011 | Not classified | Z-0048-2012 | Software design | The Abbott m2000rt System software has software bug which can affect customers who manually enter a Test Order onto the m2000rt and sorts a column on the calibration or control grids of the Test Order screen by double clicking the column… |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 4.7 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K123955 (Life Technologies Corporation, 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K012966.
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. 2010, 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 Abbott m2000 system is intended for in vitro diagnostic use in performing FDA cleared and approved nucleic acid testing in clinical laboratories. It comprises the Abbott m2000sp and the Abbott m2000rt instruments.
The Abbott m2000sp is an automated system for performing sample preparation for nucleic acid testing.
The Abbott m2000rt is an automated system for performing fluorescence-based POR to provide quantitative and qualitative detection of nucleic acid sequences.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092705 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092705: Abbott M2000SP and Abbott M2000RT, Models 9K14-01 (G-Series), 9K14-02 (E-Series), 9K1501.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092705
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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