FDA product code LON: System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
LON is the FDA product code for system, test, automated, antimicrobial susceptibility, short incubation. It is a Class II device, regulated under 21 CFR 866.1645 and reviewed by the Microbiology panel. FDA has cleared 289 510(k) submissions under LON, 28 in the last five years, from 18 different applicants. The average 510(k) review took 90 days (median 58); 99 days on average over the last three years. 12 PMA applications cite this product code. FDA has posted 238 recalls for LON devices, 27 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
| Device class | Class II |
| Regulation | 21 CFR 866.1645 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) |
510(k) clearances per year for LON
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 10 | 157 |
| 2018 | 4 | 106 |
| 2019 | 8 | 76 |
| 2020 | 5 | 117 |
| 2021 | 5 | 239 |
| 2022 | 8 | 201 |
| 2023 | 11 | 254 |
| 2024 | 2 | 86 |
| 2025 | 5 | 145 |
| 2026 | 2 | 66 |
Compare with all 510(k) review times · Search every LON clearance
Top LON applicants
| Applicant | Clearances | Latest |
|---|---|---|
| bioMerieux, Inc. | 113 | 2026-04-15 |
| Becton, Dickinson & CO | 106 | 2013-07-10 |
| Dade Behring, Inc. | 37 | 2007-08-20 |
| Becton, Dickinson and Company | 14 | 2025-08-08 |
| Bd Diagnostic Systems | 3 | 2003-09-11 |
13 more applicants have LON clearances. See the full list in Caduvo.
Most recent LON clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260282 | bioMerieux, Inc. | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | 2026-04-15 | 76 |
| K260281 | BIOMERIEUX | VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) | 2026-03-26 | 56 |
| K251579 | bioMerieux, Inc. | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) | 2025-08-21 | 90 |
| K251713 | Becton, Dickinson and Company | BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) | 2025-08-08 | 66 |
| K250447 | Becton, Dickinson and Company | BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) | 2025-05-19 | 90 |
Recalls for LON devices
238 product recalls in 44 recall events; 27 initiated in the last five years and 27 still open. Most recent: 2026-07-24.
| Year | Recalls |
|---|---|
| 2017 | 44 |
| 2018 | 9 |
| 2019 | 3 |
| 2020 | 8 |
| 2021 | 2 |
| 2022 | 15 |
| 2024 | 6 |
| 2025 | 2 |
| 2026 | 4 |
Frequently asked questions
What is FDA product code LON?
LON is the FDA product code for system, test, automated, antimicrobial susceptibility, short incubation. It is a Class II device, regulated under 21 CFR 866.1645 and reviewed by the Microbiology panel.
What device class is LON?
Class II, regulation 21 CFR 866.1645. Typical premarket route: 510(k).
How long does a 510(k) take for product code LON?
Across 289 cleared submissions the average was 90 days from receipt to decision (median 58).
Which companies have the most LON clearances?
bioMerieux, Inc. (113); Becton, Dickinson & CO (106); Dade Behring, Inc. (37); Becton, Dickinson and Company (14); Bd Diagnostic Systems (3).
Have LON devices been recalled?
Yes: 238 product recalls across 44 recall events; the most recent began 2026-07-24.
Next steps
- Run an FDA pathway report with predicate devices for product code LON
- Run a recall and safety report across every LON manufacturer
- Watch product code LON for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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