Product code LON: 510(k) clearances and predicates
Product code LON covers VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance. FDA lists 289 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
289 clearances on file under product code LON. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 8 |
| 2023 | 11 |
| 2024 | 2 |
| 2025 | 5 |
| 2026 so far | 2 |
Recent clearances
Newest LON clearances in the FDA index, with applicant and decision date:
- K260282, VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance, applicant bioMerieux, Inc., decided 2026-04-15. FDA record
- K260281, VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL), applicant BIOMERIEUX, decided 2026-03-26. FDA record
- K251579, VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL), applicant bioMerieux, Inc., decided 2025-08-21. FDA record
- K251713, BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL), applicant Becton, Dickinson and Company, decided 2025-08-08. FDA record
- K250447, BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL), applicant Becton, Dickinson and Company, decided 2025-05-19. FDA record
- K234012, VITEK COMPACT PRO, applicant bioMerieux, Inc., decided 2025-03-14. FDA record
- K250344, BD Phoenix Automated Microbiology System, applicant Becton, Dickinson and Company, decided 2025-03-06. FDA record
- K233986, BD Phoenix Automated Microbiology System - GN Ciprofloxacin (0.01564 µg/mL), applicant Becton, Dickinson and Company, decided 2024-03-15. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL), VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL). Watch new LON clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code LON?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent LON clearances include VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance.
How many 510(k) clearances use product code LON?
289 at the time this page was generated, from openFDA records.
How do I find a predicate device under LON?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new LON clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.