510(k) · Cleared
Recalled · Class II · 2026VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
bioMerieux, Inc. · LON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Cleared on Dec 19, 2017 as substantially equivalent to K161510 (bioMerieux, Inc., 2017) after an 84-day review. Its family tree reaches back 8 generations to 2003. It has been recalled once.
- Decided
- Dec 19, 2017
- Review
- 84 days
- Class
- Class II
- Product code
- LON
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 8 generations to K032788 (2003). No later device cites it as a predicate yet.
- Root · 8 generations backK032788 Vitek 2 Gram Negative GatifloxacinbioMerieux, Inc. · 2003
- 7 generations backK041982 Vitek 2 Gram Negative ErtapenembioMerieux, Inc. · 2004 · Recalled
- 6 generations backK072038 Vitek 2 Gram Negative LevofloxacinbioMerieux, Inc. · 2007
- 5 generations backK082346 Vitek 2 Gram Negative DoripenembioMerieux, Inc. · 2009
- 4 generations backK091899 Vitek 2 Gram Negative MeropenembioMerieux, Inc. · 2009
- 3 generations backK103752 Vitek 2 Systems (PC) 5.02 SoftwarebioMerieux, Inc. · 2011
- 2 generations backK121546 Vitek 2 Gram Negative DoxycyclinebioMerieux, Inc. · 2012
- 1 generation backK161510 VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL)bioMerieux, Inc. · 2017
- This deviceK172944 VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mLbioMerieux, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K032788 | Vitek 2 Gram Negative Gatifloxacin | bioMerieux, Inc. | 2003 | — |
| −7 | K041982 | Vitek 2 Gram Negative Ertapenem | bioMerieux, Inc. | 2004 | 1 |
| −6 | K072038 | Vitek 2 Gram Negative Levofloxacin | bioMerieux, Inc. | 2007 | — |
| −5 | K082346 | Vitek 2 Gram Negative Doripenem | bioMerieux, Inc. | 2009 | — |
| −4 | K091899 | Vitek 2 Gram Negative Meropenem | bioMerieux, Inc. | 2009 | — |
| −3 | K103752 | Vitek 2 Systems (PC) 5.02 Software | bioMerieux, Inc. | 2011 | — |
| −2 | K121546 | Vitek 2 Gram Negative Doxycycline | bioMerieux, Inc. | 2012 | — |
| −1 | K161510 | VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL) | bioMerieux, Inc. | 2017 | — |
| 0 (this device) | K172944 | VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mL | bioMerieux, Inc. | 2017 | — |
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 LON? 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 LON device
- #1 K260619 VITEK 2 AST-Streptococcus Cefepime (<=0.06 –…score 13.3 · 5 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 |
|---|---|---|---|
| * | K161510 | VTEK 2 AST-GN Ceftolozane/Tazobactam (<=0.25 - >= 32 mcg/mL)Summary page 5…ST-GN Ceftazidime/Avibactam C. Predicate Device: VITEK® 2 AST-GN Ceftolozane/Tazobactam (≤0.25 - ≥ 32 μg/ml) (K161510 ) D. 510(k) Summary: VITEK® 2 Gram Negative Ceftazidime/Avibactam is designed for antimicrobial susceptibility testing of Gram… | 2017 |
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 |
|---|---|---|---|---|
| Jan 5, 2026 | Class II | Z-1236-2026 | Under Investigation by firm | Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 1 company; a new generation was cleared every 1.5 years on median.
- 1 of the 8 ancestors has a recall of any class.
How does its category compare?
All LON devicesLON System, Test, Automated, Antimicrobial Susceptibility, Short Incubation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · LON
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LON
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LON
1in 2025
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · LON
690in 2025
MAUDE reports naming product code LON, 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 | 19 | 50 | 0 | 3 |
| 2008 | 7 | 66 | 1 | 1 |
| 2009 | 8 | 76 | 0 | 0 |
| 2010 | 1 | — | 116 | 3 |
| 2011 | 8 | 85 | 3 | 4 |
| 2012 | 10 | 200 | 3 | 9 |
| 2013 | 7 | 115 | 0 | 3 |
| 2014 | 4 | 90 | 2 (2) | 10 |
| 2015 | 0 | — | 0 | 41 |
| 2016 | 3 | 242 | 2 | 94 |
| 2017 | 10 | 89 | 1 | 197 |
| 2018 | 4 | 88 | 6 | 512 |
| 2019 | 8 | 84 | 1 | 315 |
| 2020 | 5 | 81 | 8 | 218 |
| 2021 | 5 | 268 | 0 | 232 |
| 2022 | 8 | 189 | 15 | 180 |
| 2023 | 11 | 210 | 0 | 453 |
| 2024 | 2 | — | 1 | 418 |
| 2025 | 5 | 90 | 1 | 690 |
| 2026 | 4 | 146 | 6 | — |
What is it indicated for?
VITEK® 2 Gram Negative Ceftazidime/Avibactam is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 Gram Negative Ceftazidime/Avibactam is a quantitative test. Ceftazidime/Avibactam has been shown to be active against most strains of the microorganisms listed…
Read the full statement (165 words)
VITEK® 2 Gram Negative Ceftazidime/Avibactam is designed for antimicrobial susceptibility testing of Gram negative bacilli and is intended for use with the VITEK® 2 and VITEK® 2 Compact Systems as a laboratory aid in the determination of in vitro susceptibility to antimicrobial agents. VITEK® 2 Gram Negative Ceftazidime/Avibactam is a quantitative test. Ceftazidime/Avibactam has been shown to be active against most strains of the microorganisms listed below, according to the FDA label for this antimicrobial.
Active both in vitro and in clinical infections:
Citrobacter freundii
Enterobacter cloacae
Escherichia coli
Klebsiella oxytoca
Klebsiella pneumoniae
Proteus mirabilis
Pseudomonas aeruginosa
The following in vitro data are available, but clinical significance is unknown:
Citrobacter koseri
Enterobacter aerogenes
Morganella morganii
Providencia stuartii
Serratia marcescens
The VITEK® 2 Antimicrobial Susceptibility Test (AST) is intended to be used with the VITEK® 2 Systems for the automated quantitative or qualitative susceptibility testing of isolated colonies for the most clinically significant aerobic gram-negative bacilli, Staphylococcus spp., Enterococcus spp., Streptococcus spp. and clinically significant yeast.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172944 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172944: VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172944
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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