FDA product code · Microbiology
LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Product code LON covers System, Test, Automated, Antimicrobial Susceptibility, Short Incubation, a Class II device regulated under 21 CFR 866.1645. FDA has cleared 289 devices in this code, 3 of them in the last 12 months. Median review time across the 289 most recent decisions is 58 days. openFDA lists 237 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 866.1645
- Review panel
- Microbiology
- Clearances
- 289
What is happening in LON right now?
LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation) has one finding. 4 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2888-2026, Z-2889-2026, Z-2715-2026, Z-0239-2026).
| Finding | How much it matters | FDA records |
|---|---|---|
| Recall | Class II recall | Z-2888-2026, Z-2889-2026, Z-2715-2026, Z-0239-2026 |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in LON?
FDA has cleared 289 devices under product code LON since the 510(k) programme began in 1976, 3 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin Resistance | bioMerieux, Inc. | |
| K260281 | VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL) | BIOMERIEUX | |
| K251579 | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) | bioMerieux, Inc. | |
| K251713 | BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL) | Becton, Dickinson and Company | |
| K250447 | BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL) | Becton, Dickinson and Company | |
| K234012 | VITEK COMPACT PRO | bioMerieux, Inc. | |
| K250344 | BD Phoenix Automated Microbiology System | Becton, Dickinson and Company | |
| K233986 | BD Phoenix Automated Microbiology System - GN Ciprofloxacin (0.01564 µg/mL) | Becton, Dickinson and Company | |
| K234000 | VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL) | bioMerieux, Inc. | |
| K232756 | Colibrí | Copan Wasp Srl |
How long does FDA review take for LON?
The median FDA review time for LON is 58 days, measured across the 289 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in LON?
openFDA lists 237 recall records against product code LON. A recall record covers one firm's corrective action and may span many device lots.
Z-2888-2026Open, ClassifiedBeckman Coulter, Inc.
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
Z-2889-2026Open, ClassifiedBeckman Coulter, Inc.
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
Z-2715-2026Open, ClassifiedbioMerieux, Inc.
Potential for false resistant carbapenem and/or cephalosporin results when analyzing samples with kits from affected lot that have pouch foil fractures.
Z-0239-2026Open, ClassifiedBecton, Dickinson and Company
Product service credentials used by some BD technical support teams to access certain BD products were accessed by an unauthorized actor. Until these product service credentials are updated, there is a risk of unauthorized access that may impact the confidentiality, integrity and/or availability of the relevant products and associated data.
Z-2671-2025Open, ClassifiedbioMerieux, Inc.
Potential for false resistant results for Colistin (cs02n) with multi-drug-resistant Pseudomonas aeruginosa and Acinetobacter baumannii complex used in specific cards
Showing the 5 most recently initiated of 237. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for LON?
MAUDE holds 1,577 adverse-event reports naming product code LON, 671 of them received in the last 12 months.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in LON unusual?
One month sits above LON's own expected range: 1 August 2025.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 22 | Insufficient history | No expected range — too little history | |
| 7 | Insufficient history | No expected range — too little history | |
| 30 | Insufficient history | No expected range — too little history | |
| 58 | Insufficient history | No expected range — too little history | |
| 31 | Insufficient history | No expected range — too little history | |
| 48 | Insufficient history | No expected range — too little history | |
| 17 | Insufficient history | No expected range — too little history | |
| 32 | Insufficient history | No expected range — too little history | |
| 16 | Insufficient history | No expected range — too little history | |
| 66 | Insufficient history | No expected range — too little history | |
| 36 | Insufficient history | No expected range — too little history | |
| 25 | Insufficient history | No expected range — too little history | |
| 29 | Insufficient history | No expected range — too little history | |
| 64 | Insufficient history | No expected range — too little history | |
| 12 | Insufficient history | No expected range — too little history | |
| 10 | Insufficient history | No expected range — too little history | |
| 13 | Insufficient history | No expected range — too little history | |
| 18 | Insufficient history | No expected range — too little history | |
| 61 | Insufficient history | No expected range — too little history | |
| 48 | Insufficient history | No expected range — too little history | |
| 36 | Insufficient history | No expected range — too little history | |
| 9 | 0–72 | Within expected (0–72) | |
| 49 | 0–53 | Within expected (0–53) | |
| 43 | 0–71 | Within expected (0–71) | |
| 15 | 0–77 | Within expected (0–77) | |
| 12 | 0–68 | Within expected (0–68) | |
| 30 | 0–60 | Within expected (0–60) | |
| 39 | 0–96 | Within expected (0–96) | |
| 295 | 0–70 | Above expected (0–70) | |
| 84 | 0–278 | Within expected (0–278) | |
| 60 | 0–266 | Within expected (0–266) | |
| 20 | 0–227 | Within expected (0–227) | |
| 28 | 0–232 | Within expected (0–232) | |
| 18 | 0–253 | Within expected (0–253) | |
| 86 | 0–202 | Within expected (0–202) | |
| 102 | 0–236 | Within expected (0–236) |
21 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike. Method: ewma_alpha_0.3_sd_2 corpus_adjusted. Counts are divided by the corpus-wide volume for that month before comparison, so a rise across all of MAUDE is not reported as a rise in LON.
What are the predicate devices in LON?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in LON?
Across the 289 most recent decisions, these applicants filed most often in LON.
| Applicant | Recent clearances |
|---|---|
| bioMerieux, Inc. | 113 |
| Becton, Dickinson & CO | 106 |
| Dade Behring, Inc. | 37 |
| Becton, Dickinson and Company | 14 |
| Bd Diagnostic Systems | 3 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
2 companies in LON file under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| Becton, Dickinson and Company | 122 | 4 |
| bioMerieux, Inc. | 116 | 4 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch LON
Get an email the morning anything changes in LON — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.