Cleared Traditional

K932570 - MARK I HUMIDIFIER

K932570 is an FDA 510(k) clearance for MARK I HUMIDIFIER, manufactured by C.F. Electronics, Inc.. The device is a Class 2 Anesthesiology device with product code BTT cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K932570 · C.F. Electronics, Inc. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
90d
Days
Class 2
Risk

K932570 is an FDA 510(k) clearance for the MARK I HUMIDIFIER. Classified as Humidifier, Respiratory Gas, (direct Patient Interface) (product code BTT), Class II - Special Controls.

Submitted by C.F. Electronics, Inc. (Commack, US). The FDA issued a Cleared decision on August 25, 1993 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K932570

510(k) Number K932570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 1993
Decision Date August 25, 1993
Days to Decision 90 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 140d · This submission: 90d
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 220
Devices cleared under the same product code (BTT) and FDA review panel - the closest regulatory comparables to K932570.
PURITAN-BENNETT CASCADE I SERIES HUMIDIFIER MODIFICATION
K936000 · Puritan Bennett Corp. · Aug 1994
MR290 HUMIDIFICATION CHAMBER SINGLE USE
K934140 · Fisher & Paykel Electronics , Ltd. · Jan 1994
RES Q AIR SYSTEM MODEL HT-1000
K926161 · C.F. Electronics, Inc. · Aug 1993
HEATED RESPIRATORY HUMIDIFIER HC100
K915460 · Fisher & Paykel Electronics , Ltd. · Jan 1993
MISTY OX LAMINAR DIFFUSER HUMIDIFIER
K923754 · Medical Molding Corp. of America · Dec 1992
MODELS MR410 & MR480 RESPIRATORY HUMIDIFIER/ACCESS
K913367 · Fisher & Paykel Electronics , Ltd. · Jun 1992
K932570 · MARK I HUMIDIFIER
Download PDF FDA Summary C.F. Electronics, Inc.