510(k) · Cleared
ClearedBD Viper Instrument
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson & CO · JQW Station, Pipetting And Diluting, For Clinical Use
Cleared on Jun 24, 2003 as substantially equivalent to K984631 (Becton Dickinson Microbiology Systems, 1999) and 3 other predicates after a 209-day review. Its family tree reaches back 1 generation to 1994. 1 later device descends from it.
- Decided
- Jun 24, 2003
- Review
- 209 days
- Class
- Class I
- Product code
- JQW
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 1 generation to K940390 (1994). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K052481BD Viper SystemBecton, Dickinson & CO · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940390 | Impact | Matrix Technologies Corp. | 1994 | — |
| 0 (this device) | K023955 | BD Viper Instrument | Becton, Dickinson & CO | 2003 | — |
| +1 | K052481 | BD Viper System | Becton, Dickinson & CO | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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 JQW? 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
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K984631 | Bdprobetec ET Chlamydia Trachomatis and Neisseria Gonorrhoeae Amplified Dna AssaySummary page 1…Pipetting System for Clinical Use Device Classification: 21 CFRs862.2750 Predicate Devices: BD ProbeTecTM ET System (K984631) Impactllmpact 2 (K940390/K961694) Mini Sample Processo… | 1999 |
| * | K940390 | ImpactSummary page 1…ssification: 21 CFRs862.2750 Predicate Devices: BD ProbeTecTM ET System (K984631) Impactllmpact 2 (K940390/K961694) Mini Sample Processor (K970616) Intended Use: The BD ViperTMinstrument is intende… | 1994 |
| * | K961694 | ImpactSummary page 1…ion: 21 CFRs862.2750 Predicate Devices: BD ProbeTecTM ET System (K984631) Impactllmpact 2 (K940390/K961694) Mini Sample Processor (K970616) Intended Use: The BD ViperTMinstrument is intended for us… | 1996 |
| * | K970616 | Mini Sampler ProcessorSummary page 1…BD ProbeTecTM ET System (K984631) Impactllmpact 2 (K940390/K961694) Mini Sample Processor (K970616) Intended Use: The BD ViperTMinstrument is intended for use as a sample processor designed for use with the BD ProbeTecTMET sys… | 1997 |
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 |
|---|---|---|---|
| K052481 | BD Viper System | 2005 | 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?
How does its category compare?
All JQW devicesJQW Station, Pipetting And Diluting, For Clinical Use: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JQW
FDA has decided no JQW device since 2007.
Median 510(k) review, days · JQW
Too few JQW 510(k)s in any year since 2007 to give a median.
Recalls per year · JQW
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JQW
11in 2025
MAUDE reports naming product code JQW, 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 | — | 2 | 41 |
| 2008 | 0 | — | 2 | 20 |
| 2009 | 0 | — | 2 | 5 |
| 2010 | 0 | — | 3 | 4 |
| 2011 | 0 | — | 2 | 32 |
| 2012 | 0 | — | 2 | 17 |
| 2013 | 0 | — | 0 | 11 |
| 2014 | 0 | — | 1 | 11 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 2 | 5 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 0 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 27 |
| 2021 | 0 | — | 0 | 30 |
| 2022 | 0 | — | 0 | 44 |
| 2023 | 0 | — | 0 | 36 |
| 2024 | 0 | — | 0 | 15 |
| 2025 | 0 | — | 0 | 11 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BD Viper instrument is intended for use as a sample processor designed for use with the BD ProbeTec ET system and the BD ProbeTec ET Chlamydia trachomatis and Neisseria gonorrhoeae assays. The BD Viper instrument automates the transfer and mixing of manually prepared and lysed samples. The BD Viper instrument incorporates heating blocks to perform assay priming and prewarming incubation steps prior to the removal and transfer of the microwells to the BD ProbeTec ET instrument for amplification and detection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023955 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023955: BD Viper Instrument.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023955
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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