Cleared Traditional

K823143 - BUBBLE HUMIDIFIERS

K823143 is an FDA 510(k) clearance for BUBBLE HUMIDIFIERS, manufactured by Seven Harvest Intl. Import & Export. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K823143 · Seven Harvest Intl. Import & Export · Anesthesiology device
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Nov 1982
Decision
35d
Days
Class 2
Risk

K823143 is an FDA 510(k) clearance for the BUBBLE HUMIDIFIERS. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Seven Harvest Intl. Import & Export (Mchenry, US). The FDA issued a Cleared decision on November 29, 1982 after a review of 35 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 Seven Harvest Intl. Import & Export devices

FDA 510(k) Submission Details - K823143

510(k) Number K823143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1982
Decision Date November 29, 1982
Days to Decision 35 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 140d · This submission: 35d
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 176
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K823143.
NEBULO 28 NEBULIZER KIT
K841158 · Inspiron Corp. · Mar 1984
CONCHATHERM LHF HUMIDIFIER HEATER
K834151 · Respiratory Care, Inc. · Jan 1984
AQUAPAK 020 HUMIDIFIER ADAPTER
K833974 · Respiratory Care, Inc. · Dec 1983
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