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Ultimate-Aire

by Hawkins Intl.

510(k) K813258

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 NumberK813258 Date5 Feb 1982ClearedStatusActive

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  • Withdrawn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, 27 Sep 2026

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

The Ultimate-Aire is a medical recirculating air cleaner. It is designed to filter and circulate air within a clinical environment.

This device is regulated under FDA 510(k) clearance K813258. It is classified as a class 2 medical device under regulation number 880.5045.

Questions

AI-generated answers, 27 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 primary function of the Ultimate-Aire?

    The Ultimate-Aire is a medical recirculating air cleaner engineered to filter and circulate air specifically within clinical environments to maintain air quality.

  • What is the regulatory status of this device?

    The Ultimate-Aire is a class 2 medical device regulated under FDA 510(k) clearance number K813258, which confirms it has been found substantially equivalent to legally marketed predicate devices.

  • Under which medical specialty is this device categorized?

    This device is categorized under the General Hospital medical specialty, as indicated by its classification under regulation number 880.5045 and its review by the General Hospital advisory committee.