510(k) · Cleared
ClearedBD Vaginal Panel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · PQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System
Cleared on Mar 6, 2023 as substantially equivalent to K201017 (Geneohm Sciences Canada, Inc. (Bd Life Sciences), 2021) after a 90-day review. Its family tree reaches back 3 generations to 2016. 1 later device descends from it.
- Decided
- Mar 6, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- PQA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN160001 (2016). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backDEN160001 BD MAX Vaginal Panel, BD MAX InstrumentGeneohm Sciences Canada, Inc. (Bd Diagnostics) · 2016
- 2 generations backK191957 BD MAX Vaginal PanelGeneohm Sciences Canada, Inc. (Bd Diagnostics) · 2019
- 1 generation backK201017 BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection KitGeneohm Sciences Canada, Inc. (Bd Life Sciences) · 2021
- This deviceK223653 BD Vaginal PanelBecton, Dickinson and Company · 2023
- Descendant · cites it directly · 0 of its ownK243725 BD Vaginal PanelBecton, Dickinson and Company · 2024
Most influential descendants
Showing 1 of 1 · See all- K243725BD Vaginal PanelBecton, Dickinson and Company · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN160001 | BD MAX Vaginal Panel, BD MAX Instrument | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2016 | — |
| −2 | K191957 | BD MAX Vaginal Panel | Geneohm Sciences Canada, Inc. (Bd Diagnostics) | 2019 | — |
| −1 | K201017 | BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection Kit | Geneohm Sciences Canada, Inc. (Bd Life Sciences) | 2021 | — |
| 0 (this device) | K223653 | BD Vaginal Panel | Becton, Dickinson and Company | 2023 | — |
| +1 | K243725 | BD Vaginal Panel | Becton, Dickinson and Company | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 PQA? 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 PQA device
- #1 K260021 cobas® BV/CVscore 12.0 · 2 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 |
|---|---|---|---|
| * | K201017 | BD MAX Vaginal Panel, BD MAX System, BD Molecular Swab Collection KitSummary page 5…l Time Nucleic Acid Amplification System NSU Instrumentation for Clinical Multiplex Test Systems Predicate Device BD MAX Vaginal Panel (DEN160001, K191957, K201017) Device Establishment Registration Number: 1119779 Intended Use The BD Vaginal Panel is an automated qualitative in vitro diag… | 2021 |
| † | DEN160001 | BD MAX Vaginal Panel, BD MAX Instrument | 2016 |
| † | K191957 | BD MAX Vaginal Panel | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K243725 | BD Vaginal Panel | 2024 | 0 |
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?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K243725 (Becton, Dickinson and Company, 2024) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K201017.
How does its category compare?
All PQA devicesPQA Vaginitis And Bacterial Vaginosis Nucleic Acid Detection System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · PQA
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PQA
87in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PQA
2in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PQA
3in 2025
MAUDE reports naming product code PQA, 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 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 2 | 0 |
| 2019 | 3 | 87 | 0 | 0 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 2 | — | 0 | 7 |
| 2023 | 2 | — | 0 | 3 |
| 2024 | 2 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The BD Vaginal Panel is an automated qualitative in vitro diagnostic test for the direct detection of DNA targets from bacteria associated with bacterial vaginosis (qualitative results reported based on detection and quantitation of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis from vaginal swabs in patients who are symptomatic for vaginitis/vaginosis. The test utilizes real-time…
Read the full statement (174 words)
The BD Vaginal Panel is an automated qualitative in vitro diagnostic test for the direct detection of DNA targets from bacteria associated with bacterial vaginosis (qualitative results reported based on detection and quantitation of targeted organism markers), Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis from vaginal swabs in patients who are symptomatic for vaginitis/vaginosis. The test utilizes real-time polymerase chain reaction (PCR) for the amplification of specific DNA targets and utilizes fluorogenic target-specific hybridization probes to detect and differentiate DNA from:
• Bacterial vaginosis markers (Individual markers not reported)
Lactobacillus spp. (L. crispatus and L. jensenii)
Gardnerella vaginalis
Atopobium vaginae
Bacterial Vaginosis Associated Bacteria-2 (BVAB-2)
Megasphaera-1
• Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis)
• Candida glabrata
• Candida krusei
• Trichomonas vaginalis
The BD Vaginal Panel is intended to aid in the diagnosis of vaginal infections in women with a clinical presentation consistent with bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis.
The BD Vaginal Panel is available for use with the BD MAX™ System or the BD COR™ System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223653 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223653: BD Vaginal Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223653
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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