Cleared Traditional

K092129 - INTERSURGICAL HEATED WIRE BREATHING SYS...

K092129 is an FDA 510(k) clearance for INTERSURGICAL HEATED WIRE BREATHING SYS..., manufactured by Intersurgical, Inc.. The device is a Class 2 Anesthesiology device with product code BZE cleared through the Traditional 510(k) pathway after a 307-day FDA review.

K092129 · Intersurgical, Inc. · Anesthesiology device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K092129

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.

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 24
Devices cleared under the same product code (BZE) and FDA review panel - the closest regulatory comparables to K092129.
ADULT EVAQUA 2' DUAL HEATED BREATHING CIRCUITS
K122432 · Fisher &Paykel Healthcare , Ltd. · Dec 2012
DUAL HEATED INFANT VREATHING CIROUITS
K103767 · Fisher &Paykel Healthcare , Ltd. · Apr 2012
RESPIRONICS DISPOSABLE HEATED WIRE CIRCUITS
K110398 · Respironics, Inc. · Jun 2011
RT 138 & RT 141 DUAL-HEATED NEONATAL BREATHING CIRCUITS
K034026 · Fisher &Paykel Healthcare , Ltd. · Jan 2005
MODIFICATION TO AIRLIFE HEATED VENTILATOR AND ANESTHESIA BREATHING CIRCUITS
K000697 · Allegiance Healthcare Corp. · Mar 2000
AIRLIFE HEATED VENTILATOR AND BREATHING CIRCUITS
K993833 · Allegiance Healthcare Corp. · Dec 1999