Cleared Traditional

K813201 - CASTLE #3241 GAS AERATOR

K813201 is an FDA 510(k) clearance for CASTLE #3241 GAS AERATOR, manufactured by Sybron Corp.. The device is a Class 2 General Hospital device with product code FLI cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K813201 · Sybron Corp. · General Hospital
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Dec 1981
Decision
48d
Days
Class 2
Risk

K813201 is an FDA 510(k) clearance for the CASTLE #3241 GAS AERATOR. Classified as Cabinet, Ethylene-oxide Gas Aerator (product code FLI), Class II - Special Controls.

Submitted by Sybron Corp. (Mchenry, US). The FDA issued a Cleared decision on December 31, 1981 after a review of 48 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6100 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sybron Corp. devices

FDA 510(k) Submission Details - K813201

510(k) Number K813201 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1981
Decision Date December 31, 1981
Days to Decision 48 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 129d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FLI Device Classification - Class 2, Special Controls

Product Code FLI Cabinet, Ethylene-oxide Gas Aerator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6100
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FLI Cabinet, Ethylene-oxide Gas Aerator

Devices cleared under the same product code (FLI) and FDA review panel - the closest regulatory comparables to K813201.
STERI-VAC(TM) AERATOR MODEL XL
K904921 · 3M Health Care, Ltd. · Dec 1990
CASTLE MODEL 3341 & 3441 & 4141 GAS AER
K831595 · Castle Co. · Jun 1983
BEAR JET 150 VENTILATOR
K830165 · Bear Medical Systems, Inc. · Apr 1983
EO EVACUATING SYSTEM I
K790677 · Castle Co. · May 1979
CASTLE MODEL 3146 GAS AERATOR
K781484 · Castle Co. · Oct 1978
PORTAGAS AERATOR
K761341 · Amsco Co. · Feb 1977