Castle Model 3341 & 3441 & 4141 Gas Aer

No FDA recalls found in the data synced 11 Oct 2026.

510(k) Number

K831595 ↗

FDA Product Code

FLI

Models / Variants

3341

3441

4141 Gas Aer

Device Class

Class II

Regulation

21 CFR Part 880.6100

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Sterilizer, Series 3000, Modification to

  Class II

  FDA 510(k) K770682 Active Cleared 20 May 1977

• Sterilizers, 3100 Series Trim Line

  Class II

  FDA 510(k) K771229 Active Cleared 2 Aug 1977

• Castle Tec-Test S.M.A.R.T. Pack

  Class II

  FDA 510(k) K833074 Active Cleared 7 Nov 1983

• Castle Tec-Test Steam Steri. Integrator

  Class II

  FDA 510(k) K770078 Active Cleared 28 Feb 1977

• Castle 7515 Utensil/Glassware Washer

  Class II

  FDA 510(k) K844089 Active Cleared 14 Jan 1985

• Castle Tec-Test Aeration Monitor

  Class II

  FDA 510(k) K761011 Active Cleared 2 Dec 1976

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