Cleared Traditional

K790896 - TWO-WAY ANESTHESIA FILTER

K790896 is the FDA 510(k) clearance for TWO-WAY ANESTHESIA FILTER by Pharmaseal Div., Baxter Healthcare Corp.. It is a Class 2 General Hospital device (product code CAH) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K790896 · Pharmaseal Div., Baxter Healthcare Corp. · General Hospital
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Jun 1979
Decision
28d
Days
Class 2
Risk

K790896 is an FDA 510(k) clearance for the TWO-WAY ANESTHESIA FILTER. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Pharmaseal Div., Baxter Healthcare Corp. (Mchenry, US). The FDA issued a Cleared decision on June 5, 1979 after a review of 28 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.5260 - 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 Pharmaseal Div., Baxter Healthcare Corp. devices

Submission Details

510(k) Number K790896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1979
Decision Date June 05, 1979
Days to Decision 28 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CAH Filter, Bacterial, Breathing-circuit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5260
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 - CAH Filter, Bacterial, Breathing-circuit

All 74
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K790896.
NON-REUSABLE UNIVERSAL NEBULIZER FILTE
K823257 · Ohio Medical Products · Dec 1982
RESPIRGARD
K802763 · Marquest Medical Products, Inc. · Nov 1980
UNIPOR BREATHING CIRCUIT FILTER
K791307 · Pall Biomedical Products Co. · Aug 1979
COPPER-TRAP
K781696 · Olympic Medical Corp. · Nov 1978
HUMIDIFIER FILTER
K780535 · Hudson Oxygen Therapy Sales Co. · Apr 1978
RESPIRATORY KIT
K772047 · American Hospital Supply Corp. · Nov 1977