Cleared Traditional

K881231 - DABC NONCONDUCTIVE HEATED ANESTH. BREAT...

K881231 is an FDA 510(k) clearance for DABC NONCONDUCTIVE HEATED ANESTH. BREAT..., manufactured by Intertech Resources, Inc.. The device is a Class 2 Anesthesiology device with product code BZE cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K881231 · Intertech Resources, Inc. · Anesthesiology device
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Jul 1988
Decision
101d
Days
Class 2
Risk

K881231 is an FDA 510(k) clearance for the DABC NONCONDUCTIVE HEATED ANESTH. BREATH. CIRCUIT. 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 Intertech Resources, Inc. (Fort Myers, US). The FDA issued a Cleared decision on July 1, 1988 after a review of 101 days - within the typical 510(k) review window.

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 Intertech Resources, Inc. devices

FDA 510(k) Submission Details - K881231

510(k) Number K881231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1988
Decision Date July 01, 1988
Days to Decision 101 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
39d faster than avg
Panel avg: 140d · This submission: 101d
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 K881231.
HEATED WIRE CIRCUITS FOR SCT 3000 HEATED HUMIDIFIER
K962220 · Marquest Medical Products, Inc. · Jan 1997
ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT
K915226 · Baxter Healthcare Corp · Jan 1993
FLEXHTR-1
K894654 · Bird Products Corp. · Aug 1990
HEATER WIRE BREATHING CIRCUIT
K873179 · Life Design Systems, Inc. · Mar 1988
TEMPERATURE CONTROLLER MODEL 17000
K781530 · Healthdyne, Inc. · Nov 1978
CONTROLLER, SERVO, INSPIRON
K780630 · C.R. Bard, Inc. · May 1978