Cleared Traditional

K810219 - PREFILLED HUMIDIFER

K810219 is an FDA 510(k) clearance for PREFILLED HUMIDIFER, manufactured by Corpak Co.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K810219 · Corpak Co. · Anesthesiology device
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Mar 1981
Decision
36d
Days
Class 2
Risk

K810219 is an FDA 510(k) clearance for the PREFILLED HUMIDIFER. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Corpak Co. (Mchenry, US). The FDA issued a Cleared decision on March 4, 1981 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5450 - the FDA anesthesiology and respiratory 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 Corpak Co. devices

FDA 510(k) Submission Details - K810219

510(k) Number K810219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1981
Decision Date March 04, 1981
Days to Decision 36 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d faster than avg
Panel avg: 140d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BTT Device Classification - Class 2, Special Controls

Product Code BTT Humidifier, Respiratory Gas, (direct Patient Interface)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5450
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 Anesthesiology devices follow this clearance model.

Regulatory Peers - BTT Humidifier, Respiratory Gas, (direct Patient Interface)

All 132
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K810219.
A QUAPAK
K811073 · Respiratory Care, Inc. · Apr 1981
NEBULIZER/HUMIDIFIER HUMIDITY CENTER-MI.
K810939 · Allied Healthcare Products, Inc. · Apr 1981
OPTI- SYSTEM
K810559 · Corpak Co. · Mar 1981
HUMIDIFIER
K802852 · Airlife, Inc. · Feb 1981
2M8101 HEATED LIQUID LEVEL CONTROLLER
K802144 · Travenol Laboratories, S.A. · Sep 1980
2C 7140 HEATED HUMIDIFER CANNISTER
K802145 · Travenol Laboratories, S.A. · Sep 1980