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FDA product code · Microbiology · Class 2

JWY: Manual Antimicrobial Susceptibility Test Systems

JWY is FDA's product code for "Manual Antimicrobial Susceptibility Test Systems": a Class 2 device classified under 21 CFR 866.1640, reviewed by the Microbiology panel.

510(k) review time for JWY

Across 69 510(k) clearances under JWY decided from 2018-01-01 to 2026-10-06, the median was 77 days from FDA receipt to decision. Half took between 56 and 90 days, and 80% were decided within 91 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, JWY, decisions 2018-01-01 to 2026-10-06 (n = 69)
Fastest19
25th percentile56
Median77
75th percentile90
80th percentile91
90th percentile197
Slowest363
Median days by decision year, JWY (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
20185112
20196018
2020665
20212665
2023857
2024906
202510614

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.

JWY in the public FDA record

Records naming JWY, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years441
Device recalls78
Establishment listings282
GUDID device identifiers405

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

9 FDA recognized consensus standards cite JWY, 5 of them recognized only in part, among them CLSI M45 3rd Edition; CLSI M07 11th Edition; CLSI M11 9th 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
  • 7-286 CLSI M11 9th Edition — Methods for Antimicrobial Susceptibility Testing of Anaerobic Bacteria; Approved Standard-Eighth Edition.
  • 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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