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FDA product code · Microbiology · Class 2

LON: System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

LON is FDA's product code for "System, Test, Automated, Antimicrobial Susceptibility, Short Incubation": a Class 2 device classified under 21 CFR 866.1645, reviewed by the Microbiology panel.

510(k) review time for LON

Across 50 510(k) clearances under LON decided from 2018-01-01 to 2026-10-06, the median was 90 days from FDA receipt to decision. Half took between 83 and 210 days, and 80% were decided within 231 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, LON, decisions 2018-01-01 to 2026-10-06 (n = 50)
Fastest28
25th percentile83
Median90
75th percentile210
80th percentile231
90th percentile385
Slowest681
Median days by decision year, LON (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
2019848
2020815
20212685
20221898
202321011
2025905

Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.

LON in the public FDA record

Records naming LON, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years289
Device recalls237
Establishment listings515

Counts of records, not of devices or events. Adverse event reports for LON are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.

FDA-recognized standards that cite LON

9 FDA recognized consensus standards cite LON, 5 of them recognized only in part, among them CLSI M45 3rd Edition; CLSI M07 11th Edition; CLSI M39 5th Edition. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 7-262 CLSI M45 3rd Edition (partial recognition) — Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria
  • 7-279 CLSI M07 11th Edition — Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
  • 7-312 CLSI M39 5th Edition — Analysis and Presentation of Cumulative Antimicrobial Susceptibility Test Data
  • 7-314 CLSI M27M44S 3rd Edition (partial recognition) — Performance Standards for Antifungal Susceptibility Testing of Yeasts
  • 7-317 CLSI M100 33rd Edition (partial recognition) — Performance Standards for Antimicrobial Susceptibility Testing
  • 7-319 CLSI M23 6th Edition — Development of In Vitro Susceptibility Test Methods Breakpoints and Quality Control Parameters
  • 7-324 CLSI M07 12th Edition — Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically
  • 7-327 CLSI M100 34th Edition (partial recognition) — Performance Standards for Antimicrobial Susceptibility Testing
  • 7-328 CLSI M100 35th Edition (partial recognition) — Performance Standards for Antimicrobial Susceptibility Testing

Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.

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