Cleared Traditional

K881451 - SIMPLEX UNIVERSAL HEATED TUBING SLEEVE

K881451 is an FDA 510(k) clearance for SIMPLEX UNIVERSAL HEATED TUBING SLEEVE, manufactured by Simplex Medical Corp.. The device is a Class 2 Anesthesiology device with product code BZE cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K881451 · Simplex Medical Corp. · Anesthesiology device
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Jun 1988
Decision
65d
Days
Class 2
Risk

K881451 is an FDA 510(k) clearance for the SIMPLEX UNIVERSAL HEATED TUBING SLEEVE. 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 Simplex Medical Corp. (Riverside, US). The FDA issued a Cleared decision on June 10, 1988 after a review of 65 days - a notably fast clearance 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: Fast-track predicate clearance. 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 - K881451

510(k) Number K881451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1988
Decision Date June 10, 1988
Days to Decision 65 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 140d · This submission: 65d
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 K881451.
BREATHING CIRCUIT W/HEATED WIRE
K880769 · Dryden Corp. · Aug 1988
DABC NONCONDUCTIVE HEATED ANESTH. BREATH. CIRCUIT
K881231 · Intertech Resources, Inc. · Jul 1988
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
K881451 · SIMPLEX UNIVERSAL HEATED TUBING SLEEVE
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