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Nicholas II Viral-Bacterial Filter

by K & G Healthcare Ind., Inc. 510(k)

Active United States

510(k) K811546

Overview

The Nicholas II Viral-Bacterial Filter is classified as a Filter, Bacterial, Breathing-Circuit, designed to remove microbial contaminants from respiratory circuits during anesthesia. It functions as a sterile barrier to prevent the transmission of bacteria and viruses between the patient and the breathing system, ensuring a safer anesthetic environment.

This filter is intended for single-use in anesthesia settings and is regulated under FDA 510(k) clearance (K811546) with a classification under Regulation 868.5260. Supplied sterile and non-reusable, it is integrated into breathing circuits to maintain air purity during surgical procedures. No additional storage or preparation is required beyond standard sterile handling procedures.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK811546 Date3 Aug 1981ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
CAH
Device Class
Class II
Regulation
21 CFR Part 868.5260
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

Other devices from K & G Healthcare Ind., Inc.

Questions

  • What is the primary purpose of the Nicholas II Viral-Bacterial Filter in anesthesia settings?

    The Nicholas II Viral-Bacterial Filter is designed to remove microbial contaminants, including bacteria and viruses, from respiratory circuits during anesthesia. It acts as a sterile barrier to prevent contamination from spreading between the patient and the breathing system, ensuring a safer anesthetic environment by maintaining air purity.

  • Is the Nicholas II Viral-Bacterial Filter reusable or intended for single-use?

    The Nicholas II Viral-Bacterial Filter is explicitly intended for single-use only in anesthesia settings. It is not designed for reuse, and the manufacturer emphasizes this in its regulatory submission.

  • How should the Nicholas II Viral-Bacterial Filter be stored before use?

    No additional storage or preparation is required beyond standard sterile handling procedures. Since it is supplied sterile, it should be stored in its original packaging until ready for use, following general sterile medical device storage guidelines.

  • What regulatory pathway was used for FDA clearance of this device?

    The Nicholas II Viral-Bacterial Filter received FDA clearance through a Traditional 510(k) pathway (K811546) under the classification Regulation 868.5260, with a decision of *Substantially Equivalent* (SESE). The submission was reviewed by the Anesthesiology Advisory Committee (AN).

  • Are there different sizes or models of the Nicholas II Viral-Bacterial Filter?

    The provided data does not specify distinct sizes or models beyond the single device name, the Nicholas II Viral-Bacterial Filter. However, the FEI numbers (e.g., 3009896423) suggest multiple lot or batch identifiers, but these are administrative tracking codes—not size or model variations. Clarification from the manufacturer would be needed for specific configurations.