Decontamination Systems For N95 Respirators

Name: Decontamination Systems For N95 Respirators (FDA product code QKY) — devices, recalls & adverse events
Creator: U.S. Food & Drug Administration

FDA product code QKY · Class N · Unknown

Registered devices

305

Adverse events

Recalls

510(k) clearances

Recent recalls

Date	Firm	Reason
2020-08-13	Battelle Memorial Institute	Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.