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FDA product code · Microbiology · Class 1

JSM: Culture Media, Non-Propagating Transport

JSM is FDA's product code for "Culture Media, Non-Propagating Transport": a Class 1 device classified under 21 CFR 866.2390, reviewed by the Microbiology panel.

510(k) review time for JSM

Across 22 510(k) clearances under JSM decided from 2018-01-01 to 2026-10-06, the median was 270 days from FDA receipt to decision. Half took between 250 and 378 days, and 80% were decided within 409 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, JSM, decisions 2018-01-01 to 2026-10-06 (n = 22)
Fastest74
25th percentile250
Median270
75th percentile378
80th percentile409
90th percentile593
Slowest1,318
Median days by decision year, JSM (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
20223445
20242719

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.

JSM in the public FDA record

Records naming JSM, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years111
Device recalls18
Establishment listings122

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

2 FDA recognized consensus standards cite JSM, 1 of them recognized only in part, among them CLSI M40-A2 (Reaffirmed: September 2019); CLSI MM13 2nd Edition. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 7-250 CLSI M40-A2 (Reaffirmed: September 2019) (partial recognition) — Quality Control of Microbiological Transport Systems; Approved Standard - Second Edition.
  • 7-300 CLSI MM13 2nd Edition — Collection Transport Preparation and Storage of Specimens for Molecular Methods

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

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