510(k) · Cleared
ClearedBacterioScan 216Dx System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bacterioscan, Inc. · QBQ System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture
Cleared on May 1, 2018 as substantially equivalent to K915796 (Bd Becton Dickinson Vacutainer Systems Preanalytic, 1992) after a 264-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- May 1, 2018
- Review
- 264 days
- Class
- Class I
- Product code
- QBQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K915796 (1992). No later device cites it as a predicate yet.
- Root · 1 generation backK915796 Bactec 9240 SystemBd Becton Dickinson Vacutainer Systems Preanalytic · 1992 · Recalled
- This deviceK172412 BacterioScan 216Dx SystemBacterioscan, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K915796 | Bactec 9240 System | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992 | 6 |
| 0 (this device) | K172412 | BacterioScan 216Dx System | Bacterioscan, Inc. | 2018 | — |
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 QBQ? 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? (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 |
|---|---|---|---|
| * | K915796 | Bactec 9240 SystemSummary page 4…BacterioScan™ 216Dx™ Laser Microbial BACTEC™ 9240 System Characteristic Growth Monitor System K915796 (New Device) (Predicate Device)… | 1992 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has a recall.
- 1 other device also cites its predicate K915796.
How does its category compare?
All QBQ devicesQBQ System, Microbial Growth Monitor Of Normally Sterile Body Fluid Culture: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · QBQ
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · QBQ
Too few QBQ 510(k)s in any year since 2007 to give a median.
Recalls per year · QBQ
No recall names QBQ since 2007.
Adverse event reports per year · QBQ
No MAUDE report names QBQ since 2007.
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 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The BacterioScan 216Dx System is a semi-automated, in vitro diagnostic system (consisting of an instrument, software, and disposable Multicuvettes) that analyzes light scattering to measure any bacterial growth directly from urine sample incubated in trypticase soy broth. The BacterioScan 216Dx is for qualitative determination (presumptive positive or presumptive negative) of bacteriuria at a density of ≥5x104 CFU/mL. The BacterioScan 216Dx results are…
Read the full statement (160 words)
The BacterioScan 216Dx System is a semi-automated, in vitro diagnostic system (consisting of an instrument, software, and disposable Multicuvettes) that analyzes light scattering to measure any bacterial growth directly from urine sample incubated in trypticase soy broth. The BacterioScan 216Dx is for qualitative determination (presumptive positive or presumptive negative) of bacteriuria at a density of ≥5x104 CFU/mL. The BacterioScan 216Dx results are intended for use in conjunction with other clinical and laboratory findings to aid in the diagnosis of Urinary Tract Infections (UTIs).
The 216Dx System is not intended to provide bacteriuria levels, bacterial identification, or differentiation. The system does not distinguish between growth of infecting, colonizing or contaminating bacteria, or if mixed urogenital flora are present. Presumptive positive urine samples must be cultured. Presumptive negative urine samples must be cultured if a low level of bacteriuria is suspected and is clinically relevant. The system also does not detect anaerobic bacteria, fungi/yeasts, fastidious organisms or those associated with sterile pyuria.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172412 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172412: BacterioScan 216Dx System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172412
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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