Cleared Traditional

INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODEL 2026,2026-CH, 2310, 2320, 2330 (K092129) - FDA 510(k) Clearance

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

K092129 · Intersurgical, Inc. · Anesthesiology device
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May 2010
Decision
307d
Days
Class 2
Risk

K092129 is an FDA 510(k) clearance for the INTERSURGICAL HEATED WIRE BREATHING SYSTEMS AND HUMIDIFICATION CHAMBERS, MODE.... 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 Intersurgical, Inc. (Liverpool, US). The FDA issued a Cleared decision on May 18, 2010 after a review of 307 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.

View all Intersurgical, Inc. devices

Submission Details

510(k) Number K092129 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2009
Decision Date May 18, 2010
Days to Decision 307 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
167d slower than avg
Panel avg: 140d · This submission: 307d
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 K092129.
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