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FDA product code · Microbiology · Class 2

PMN: Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

PMN is FDA's product code for "Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays": a Class 2 device classified under 21 CFR 866.3920, reviewed by the Microbiology panel.

510(k) review time for PMN

Across 27 510(k) clearances under PMN decided from 2018-01-01 to 2026-10-06, the median was 88 days from FDA receipt to decision. Half took between 61 and 113 days, and 80% were decided within 152 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, PMN, decisions 2018-01-01 to 2026-10-06 (n = 27)
Fastest15
25th percentile61
Median88
75th percentile113
80th percentile152
90th percentile295
Slowest615
Median days by decision year, PMN (years with enough clearances to compute). The partial final year counts only submissions already decided, so its median runs low.
YearMedian daysn
2019716
2026 (to 10-06, partial)845

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.

PMN in the public FDA record

Records naming PMN, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years32

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

No FDA recognized consensus standard cites PMN by product code. Horizontal standards such as biocompatibility, sterilization and software standards can still apply.

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

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