Cleared Traditional

RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS (K034026) - FDA 510(k) Clearance

Class II Anesthesiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K034026 · Fisher &Paykel Healthcare , Ltd. · Anesthesiology device
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Jan 2005
Decision
380d
Days
Class 2
Risk

K034026 is an FDA 510(k) clearance for the RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS. 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 Fisher &Paykel Healthcare , Ltd. (Auckland, NZ). The FDA issued a Cleared decision on January 12, 2005 after a review of 380 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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.

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Submission Details

510(k) Number K034026 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2003
Decision Date January 12, 2005
Days to Decision 380 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
241d slower than avg
Panel avg: 139d · This submission: 380d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 11
Devices cleared under the same product code (BZE) and FDA review panel - the closest regulatory comparables to K034026.
Neonatal ConchaSmart Breathing Circuits
K173280 · Teleflexmedical, Inc. · Aug 2018
RESPIRONICS REUSABLE HEATED TUBING
K140424 · Respironics, Inc. · Nov 2014
RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS
K110398 · Respironics, Inc. · Jun 2011
ISOTHERMAL HEATED VENTILATOR & ANESTHESIA CIRCUIT
K915226 · Baxter Healthcare Corp · Jan 1993
CONTROLLER, SERVO, INSPIRON
K780630 · C.R. Bard, Inc. · May 1978