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FDA product code · General Hospital · Class 2

MED: Sterilant, Medical Devices

MED is FDA's product code for "Sterilant, Medical Devices": a Class 2 device classified under 21 CFR 880.6885, reviewed by the General Hospital panel.

510(k) review time for MED

Across 12 510(k) clearances under MED decided from 2018-01-01 to 2026-10-06, the median was 61 days from FDA receipt to decision. Half took between 48 and 111 days, and 80% were decided within 116 days. These are past clearances, not a forecast for a new submission.

Days from FDA receipt to 510(k) decision, MED, decisions 2018-01-01 to 2026-10-06 (n = 12)
Fastest14
25th percentile48
Median61
75th percentile111
80th percentile116
90th percentile141
Slowest313

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.

MED in the public FDA record

Records naming MED, from openFDA (snapshot of 2026-09-15)
510(k) clearances, all years64
Device recalls21
Establishment listings156
GUDID device identifiers501

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

13 FDA recognized consensus standards cite MED, among them AOAC 6.2.02:2006; AOAC 6.2.03:2006; AOAC 6.2.05:2006. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.

  • 14-212 AOAC 6.2.02:2006 — Official Method 991.47 Testing Disinfectants Against Salmonella choleraesuis Hard Surface Carrier Test Method
  • 14-213 AOAC 6.2.03:2006 — Official Method 991.48 Testing Disinfectants Against Staphylococcus aureus Hard Surface Carrier Test Method
  • 14-215 AOAC 6.2.05:2006 — Official Method 991.49 Testing Disinfectants Against Pseudomonas aeruginosaHard Surface Carrier Test Method
  • 14-217 AOAC 6.3.02:2006 — Official Method 955.17 Fungicidal Activity of Disinfectants Using Trichophyton mentagrophytes
  • 14-397 AOAC 6.2.04:2013 — Official Method 955.15 Testing Disinfectants Against Staphylococcus aureusUse-Dilution Method
  • 14-398 AOAC 6.3.05:2013 — Official Method 966.04 Sporicidal Activity of Disinfectants Method I
  • 14-399 AOAC 6.3.06:2012 — Official Method 965.12 Tuberculocidal Activity of Disinfectants
  • 14-412 AOAC 6.2.01:2013 — Official Method 955.14 Testing Disinfectants Against Salmonella choleraesuis Use-Dilution Method
  • 14-413 AOAC 6.2.06:2013 — Official Method 964.02 Testing Disinfectants Against Pseudomonas aeruginosa Use-Dilution Method
  • 14-432 ANSI AAMI ST58:2013/(R)2018 — Chemical sterilization and high-level disinfection in health care facilities
  • 14-551 ISO 14160 Third edition 2020-09 — Sterilization of health care products - Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives - Requirements for characterization development validation and routine control of a sterilization process for medical devices
  • 14-597 AAMI ANSI ST108:2023 — Water for the processing of medical devices
  • 14-607 ANSI AAMI ST58:2024 — Chemical sterilization and high-level disinfection in health care facilities

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

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