Cleared Traditional

K962220 - HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER

K962220 is an FDA 510(k) clearance for HEATED WIRE CIRCUITS FOR SCT 3000 HEATE..., manufactured by Marquest Medical Products, Inc.. The device is a Class 2 Anesthesiology device with product code BZE cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K962220 · Marquest Medical Products, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
218d
Days
Class 2
Risk

K962220 is an FDA 510(k) clearance for the HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER. Classified as Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer within the BZE classification (a category for neonatal and pediatric respiratory circuit components), Class II - Special Controls.

Submitted by Marquest Medical Products, Inc. (Englewood, US). The FDA issued a Cleared decision on January 14, 1997 after a review of 218 days - an extended review cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5270 - 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. Neonatal respiratory circuit components typically face extended FDA review due to heightened safety scrutiny for pediatric patient populations - the 176-day cycle reflects this additional regulatory diligence.

View all Marquest Medical Products, Inc. devices

FDA 510(k) Submission Details - K962220

510(k) Number K962220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 1996
Decision Date January 14, 1997
Days to Decision 218 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
78d slower than avg
Panel avg: 140d · This submission: 218d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

BZE Device Classification - Class 2, Special Controls

Product Code BZE Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5270
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 - BZE Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer

All 34
Devices cleared under the same product code (BZE) and FDA review panel - the closest regulatory comparables to K962220.
MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS
K000697 · Allegiance Healthcare Corp. · Mar 2000
AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS
K993833 · Allegiance Healthcare Corp. · Dec 1999
CRITERION, CRITERION I.V., MODIFIED
K952267 · Nova-Ventrx · Dec 1997
ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT
K915226 · Baxter Healthcare Corp · Jan 1993
FLEXHTR-1
K894654 · Bird Products Corp. · Aug 1990
BREATHING CIRCUIT W/HEATED WIRE
K880769 · Dryden Corp. · Aug 1988