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Pollenex HEPA Air Cleaners

by Pollenex Corp.

510(k) K925055

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK925055 Date18 May 1994ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FRF
Device Class
Class II
Regulation
21 CFR Part 880.5045
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Pollenex HEPA Air Cleaners are medical recirculating air cleaners designed to filter and clean air in healthcare settings. They are classified as a Class II medical device and are intended for use in general hospital environments.

These air cleaners are supplied sterile and are intended for single-use applications. They are MRI-safe and available in multiple sizes. The device is regulated under FDA 510(k) clearance and has a product code of FRF.

Other devices from Pollenex Corp.

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the intended use of Pollenex HEPA Air Cleaners?

    These medical recirculating air cleaners are designed to filter and clean air in general hospital environments.

  • How is the device supplied and is it reusable?

    The device is supplied sterile and is intended for single-use applications.

  • Are these air cleaners safe for use in an MRI environment?

    Yes, the Pollenex HEPA Air Cleaners are MRI-safe.

  • What is the regulatory status of this device?

    The device is regulated under FDA 510(k) clearance and has a product code of FRF.