Cleared Traditional

K842597 - RESPIRATORY GAS HUMIDIFIER

K842597 is an FDA 510(k) clearance for RESPIRATORY GAS HUMIDIFIER, manufactured by Applinc. The device is a Class 2 Anesthesiology device with product code BZE cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K842597 · Applinc · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1985
Decision
197d
Days
Class 2
Risk

K842597 is an FDA 510(k) clearance for the RESPIRATORY GAS 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 Applinc (San Diego, US). The FDA issued a Cleared decision on January 16, 1985 after a review of 197 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.

FDA 510(k) Submission Details - K842597

510(k) Number K842597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1984
Decision Date January 16, 1985
Days to Decision 197 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 140d · This submission: 197d
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 36
Devices cleared under the same product code (BZE) and FDA review panel - the closest regulatory comparables to K842597.
CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL
K881625 · Respiratory Care, Inc. · Jun 1988
HEATER WIRE BREATHING CIRCUIT
K873179 · Life Design Systems, Inc. · Mar 1988
DISPOSABLE HEATED WIRE LOOPS 48 AND 72
K860941 · Intec Medical, Inc. · Apr 1986
TEMPERATURE CONTROLLER MODEL 17000
K781530 · Healthdyne, Inc. · Nov 1978
CONTROLLER, SERVO, INSPIRON
K780630 · C.R. Bard, Inc. · May 1978
K842597 · RESPIRATORY GAS HUMIDIFIER
Download PDF Applinc