Cleared Traditional

K962220 - HEATED WIRE CIRCUITS FOR SCT 3000 HEATE...

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 21
Devices cleared under the same product code (BZE) and FDA review panel - the closest regulatory comparables to K962220.
RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS
K034026 · Fisher &Paykel Healthcare , Ltd. · Jan 2005
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
ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT
K915226 · Baxter Healthcare Corp · Jan 1993
FLEXHTR-1
K894654 · Bird Products Corp. · Aug 1990
DABC NONCONDUCTIVE HEATED ANESTH. BREATH. CIRCUIT
K881231 · Intertech Resources, Inc. · Jul 1988