PMA · Approved
Recalled · Class II · 2016BD Prepstain System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bd Diagnostic Systems · MKQ Processor, Cervical Cytology Slide, Automated
Approved on Jun 17, 1999 through premarket approval, which rests on the device’s own clinical evidence after a 766-day review. It has been recalled 11 times.
- Decided
- Jun 17, 1999
- Review
- 766 days
- Class
- Class III
- Product code
- MKQ
- Recalls
- 11
PMA approvals rest on their own clinical evidence and do not claim a predicate, so this family tree starts here.
P970018 has 36 supplements since 2000: changes to the approved device, its labelling or its manufacturing, each approved separately.
PMA supplements approved per year
View FIG. 1 as a table
| Year | Supplements approved |
|---|---|
| 2000 | 1 |
| 2001 | 2 |
| 2002 | 1 |
| 2003 | 2 |
| 2004 | 1 |
| 2005 | 2 |
| 2007 | 1 |
| 2008 | 1 |
| 2009 | 3 |
| 2010 | 4 |
| 2011 | 2 |
| 2012 | 1 |
| 2013 | 2 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 4 |
| 2018 | 2 |
| 2021 | 3 |
| 2023 | 1 |
| 2024 | 1 |
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?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 12, 2016 | Class II | Z-0877-2017 | Nonconforming Material/Component | BD has confirmed that a portion of BD SurePath" collection vials associated with specific production lots may contain caps that are cracked which can lead to leaking of the preservative fluid. |
| Mar 22, 2012 | Class III | Z-1811-2012 | Component design/selection | The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes |
| Mar 22, 2012 | Class III | Z-1812-2012 | Component design/selection | The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes |
| Mar 22, 2012 | Class III | Z-1815-2012 | Component design/selection | The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes |
| Mar 22, 2012 | Class III | Z-1814-2012 | Component design/selection | The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes |
| Mar 22, 2012 | Class III | Z-1813-2012 | Component design/selection | The PrepStain Syringing Pipettes may not dispense the minimum volume of 7.5 mL of the sample due to leaking. This event resulted in an increase in complaints of leaking syringing pipettes |
| Dec 8, 2011 | Class II | Z-2085-2012 | Nonconforming Material/Component | Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions. |
| Dec 8, 2011 | Class II | Z-2087-2012 | Nonconforming Material/Component | Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions. |
| Dec 8, 2011 | Class II | Z-2088-2012 | Nonconforming Material/Component | Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions. |
| Dec 8, 2011 | Class II | Z-2086-2012 | Nonconforming Material/Component | Some Prep Stain Kit, 1.2 DiTi Cones have been found to be leaking and the PrepStain Preparation kits contain incorrect preventive maintenance (PM) instructions. |
| Sep 26, 2008 | Not classified | Z-1090-2009 | Software change control | Software Error in the non-gyn program of some devices may cause non-gyn samples to be incorrectly transferred from centrifuge tubes to slides potentially result in mismatched patient results. |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
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/P970018 · printed Nov 6, 2026
Cite this page
510(k) Report. “P970018: BD Prepstain System.” Lineage record from FDA PMA data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/P970018
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026