Cleared Traditional

K884150 - MODIFIED CONCHATHERM III CONTROLLED HEATER

K884150 is an FDA 510(k) clearance for MODIFIED CONCHATHERM III CONTROLLED HEATER, manufactured by Respiratory Care, Inc.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K884150 · Respiratory Care, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1988
Decision
49d
Days
Class 2
Risk

K884150 is an FDA 510(k) clearance for the MODIFIED CONCHATHERM III CONTROLLED HEATER. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by Respiratory Care, Inc. (Arlington Heights, US). The FDA issued a Cleared decision on November 21, 1988 after a review of 49 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 Respiratory Care, Inc. devices

FDA 510(k) Submission Details - K884150

510(k) Number K884150 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1988
Decision Date November 21, 1988
Days to Decision 49 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
91d faster than avg
Panel avg: 140d · This submission: 49d
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 K884150.
HEATED RESPIRATORY HUMIDIFIER
K892817 · Fisher & Paykel Electronics , Ltd. · Dec 1989
VHS 820 HUMIDIFIER, MODIFICATION
K893034 · Bear Medical Systems, Inc. · Jul 1989
MODEL MR2000 HEATED RESPIRATORY HUMIDIFIER
K881970 · Fisher &Paykel Healthcare , Ltd. · Mar 1989
STERILE INHALATION WATER TRANSFER SET
K882582 · Intertech Resources, Inc. · Sep 1988
MARQUEST SCT 2000, HEATED HUMIDIFICATION SYSTEM
K880979 · Marquest Medical Products, Inc. · Jul 1988
INTERTECH STERILE WATER FOR INHALATION
K881184 · Delmed, Inc. · May 1988