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FDA product code · Microbiology · Class 2

JTN: Susceptibility Test Discs, Antimicrobial

JTN is FDA's product code for "Susceptibility Test Discs, Antimicrobial": a Class 2 device classified under 21 CFR 866.1620, reviewed by the Microbiology panel.

510(k) review time for JTN

Across 29 510(k) clearances under JTN decided from 2018-01-01 to 2026-10-06, the median was 66 days from FDA receipt to decision. Half took between 52 and 91 days, and 80% were decided within 195 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, JTN, decisions 2018-01-01 to 2026-10-06 (n = 29)
Fastest12
25th percentile52
Median66
75th percentile91
80th percentile195
90th percentile234
Slowest672

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.

JTN in the public FDA record

Records naming JTN, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years331
Device recalls47
Establishment listings256

Counts of records, not of devices or events. Adverse event reports for JTN 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 JTN

15 FDA recognized consensus standards cite JTN, 9 of them recognized only in part, among them CLSI M51-A (Replaces M51-P); CLSI M45 3rd Edition; CLSI M27 4th Edition. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 7-243 CLSI M51-A (Replaces M51-P) (partial recognition) — Method for Antifungal Disk Diffusion Susceptibility Testing of Nondermatophyte Filamentous Fungi; Approved Guideline
  • 7-262 CLSI M45 3rd Edition (partial recognition) — Methods for Antimicrobial Dilution and Disk Susceptibility Testing of Infrequently Isolated or Fastidious Bacteria
  • 7-278 CLSI M27 4th Edition — Reference Method for Broth Dilution Antifungal Susceptibility Testing of Yeasts
  • 7-280 CLSI M02 13th Edition — Performance Standards for Antimicrobial Disk Susceptibility Tests
  • 7-287 CLSI M44-S3 (2018) — Zone Diameter Interpretive Standards Corresponding Minimal Inhibitory Concentration (MIC) Interpretive Breakpoints and Quality Control Limits for Antifungal Disk Diffusion Susceptibility Testing of Yeasts; Third Informational Supplement
  • 7-288 CLSI M24 3rd Edition — Susceptibility Testing of Mycobacteria Nocardiae and other Aerobic Actinomycetes
  • 7-292 CLSI M62 1st Edition (partial recognition) — Performance Standards for Susceptibility Testing of Mycobacteria Nocardia spp. and other Aerobic Actinomycetes
  • 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
  • 7-325 CLSI M02 14th Edition (partial recognition) — Performance Standards for Antimicrobial Disk Susceptibility Tests
  • 7-326 CLSI M24S 2nd Edition (partial recognition) — Performance Standards for Susceptibility Testing of Mycobacteria Nocardia spp. and Other Aerobic Actinomycetes
  • 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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