Cleared Traditional

K780535 - HUMIDIFIER FILTER

K780535 is an FDA 510(k) clearance for HUMIDIFIER FILTER, manufactured by Hudson Oxygen Therapy Sales Co.. The device is a Class 2 General Hospital device with product code CAH cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K780535 · Hudson Oxygen Therapy Sales Co. · General Hospital
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Apr 1978
Decision
24d
Days
Class 2
Risk

K780535 is an FDA 510(k) clearance for the HUMIDIFIER FILTER. Classified as Filter, Bacterial, Breathing-circuit (product code CAH), Class II - Special Controls.

Submitted by Hudson Oxygen Therapy Sales Co. (Mchenry, US). The FDA issued a Cleared decision on April 27, 1978 after a review of 24 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 Hudson Oxygen Therapy Sales Co. devices

FDA 510(k) Submission Details - K780535

510(k) Number K780535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 1978
Decision Date April 27, 1978
Days to Decision 24 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
105d faster than avg
Panel avg: 129d · This submission: 24d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CAH Device Classification - Class 2, Special Controls

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 114
Devices cleared under the same product code (CAH) and FDA review panel - the closest regulatory comparables to K780535.
UNIPOR BREATHING CIRCUIT FILTER
K791307 · Pall Biomedical Products Co. · Aug 1979
TWO-WAY ANESTHESIA FILTER
K790896 · Pharmaseal Div., Baxter Healthcare Corp. · Jun 1979
COPPER-TRAP
K781696 · Olympic Medical Corp. · Nov 1978
RESPIRATORY KIT
K772047 · American Hospital Supply Corp. · Nov 1977
MUFFLER, AIR PUMP
K770392 · Cutter Laboratories, Inc. · Mar 1977
FILTER, AIR, CUTTER MAINLINE
K770375 · Cutter Laboratories, Inc. · Mar 1977