PMA · Approved
ApprovedThinprep (R) Processor, Model TP 2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hologic, Inc. · MKQ Processor, Cervical Cytology Slide, Automated
Approved on May 20, 1996 through premarket approval, which rests on the device’s own clinical evidence after a 180-day review. 22 later devices descend from it.
- Decided
- May 20, 1996
- Review
- 180 days
- Class
- Class III
- Product code
- MKQ
- Recalls
- None
22 later devices descend from it, 1 citing it directly.
- This deviceP950039 Thinprep (R) Processor, Model TP 2000Hologic, Inc. · 1996
- Descendant · cites it directly · 21 of its ownK043224 Gen-Probe Aptima Combo 2 AssayGen-Probe, Inc. · 2005
- Descendant · 2 generations on · 11 of its ownK092704 Abbott Realtime CT/NG and Abbott Multi-Collect Specimen Collection…Abbott Molecular, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 10 of its ownK110923 Cobas 4800 CT / NG TestRoche Molecular Systems, Inc. · 2012 · Recalled
- Descendant · 4 generations on · 9 of its ownK132270 Cobas CT/NG V2.0 TestRoche Molecular Systems, Inc. · 2013
- Descendant · 4 generations on · 7 of its ownK163184 cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc. · 2017
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K043224Gen-Probe Aptima Combo 2 AssayGen-Probe, Inc. · 2005 · cites it directly21descendants
- K092704Abbott Realtime CT/NG and Abbott Multi-Collect Specimen Collection Kit, Models 8L07-91…Abbott Molecular, Inc. · 2010 · 2 generations on11descendants
- K110923Cobas 4800 CT / NG TestRoche Molecular Systems, Inc. · 2012 · 3 generations on10descendants
- K132270Cobas CT/NG V2.0 TestRoche Molecular Systems, Inc. · 2013 · 4 generations on9descendants
- K163184cobas® CT/NG v2.0 TestRoche Molecular Systems, Inc. · 2017 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | P950039 | Thinprep (R) Processor, Model TP 2000 | Hologic, Inc. | 1996 | — |
| +1 | K043224 | Gen-Probe Aptima Combo 2 Assay | Gen-Probe, Inc. | 2005 | — |
| +2 | K092704 | Abbott Realtime CT/NG and Abbott Multi-Collect Specimen Collection Kit, Models… | Abbott Molecular, Inc. | 2010 | 1 |
| +3 | K110923 | Cobas 4800 CT / NG Test | Roche Molecular Systems, Inc. | 2012 | 2 |
| +4 | K132270 | Cobas CT/NG V2.0 Test | Roche Molecular Systems, Inc. | 2013 | — |
| +4 | K163184 | cobas® CT/NG v2.0 Test | Roche Molecular Systems, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 0 |
Sources: FDA PMA database (decision fields and supplements), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MKQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
PMA decisions do not claim a predicate device.
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043224 | Gen-Probe Aptima Combo 2 Assay | 2005 | 21 |
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?
- Of its descendants, K043224 (Gen-Probe, Inc., 2005) has gone furthest, with 21 descendants of its own.
How does its category compare?
All MKQ devicesMKQ Processor, Cervical Cytology Slide, Automated: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MKQ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MKQ
Too few MKQ 510(k)s in any year since 2007 to give a median.
Recalls per year · MKQ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MKQ
38in 2025
MAUDE reports naming product code MKQ, 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 | 5 | — | 0 | 7 |
| 2008 | 5 | — | 1 | 8 |
| 2009 | 4 | — | 0 | 6 |
| 2010 | 5 | — | 0 | 18 |
| 2011 | 2 | — | 15 | 19 |
| 2012 | 2 | — | 0 | 6 |
| 2013 | 2 | — | 0 | 6 |
| 2014 | 7 | — | 0 | 16 |
| 2015 | 2 | — | 0 | 22 |
| 2016 | 6 | — | 1 | 28 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 3 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 1 |
| 2021 | 4 | — | 0 | 24 |
| 2022 | 0 | — | 0 | 17 |
| 2023 | 1 | — | 0 | 77 |
| 2024 | 1 | — | 0 | 56 |
| 2025 | 1 | — | 0 | 38 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/P950039 · printed Nov 6, 2026
Cite this page
510(k) Report. “P950039: Thinprep (R) Processor, Model TP 2000.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P950039
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026