Cleared Traditional

K252066 - inspired™ Heated Breathing Circuit (510-008)

Also marketed or referenced as:
inspired™ Heated Breathing Circuit (510-009) inspired™ Auto-feed Humidification Chamber (VHC10) inspired™ Auto-feed Humidification Chamber (VHC20)

K252066 is an FDA 510(k) clearance for inspired Heated Breathing Circuit (510-008), manufactured by Vincent Healthcare Products Limited. The device is a Class 2 Anesthesiology device with product code BZE cleared through the Traditional 510(k) pathway after a 352-day FDA review.

K252066 · Vincent Healthcare Products Limited · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2026
Decision
352d
Days
Class 2
Risk

K252066 is an FDA 510(k) clearance for the inspired™ Heated Breathing Circuit (510-008). 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 Vincent Healthcare Products Limited (Kowloon, HK). The FDA issued a Cleared decision on June 18, 2026 after a review of 352 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 Vincent Healthcare Products Limited devices

FDA 510(k) Submission Details - K252066

510(k) Number K252066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2025
Decision Date June 18, 2026
Days to Decision 352 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
212d slower than avg
Panel avg: 140d · This submission: 352d
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 Consultant

ProMedic, LLC
Paul Dryden

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - BZE Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer

All 34
Devices cleared under the same product code (BZE) and FDA review panel - the closest regulatory comparables to K252066.
Hudson RCI® Infant Dri-TechTM Breathing Circuits (HUD99060 / Dri-Tech with 78” Infant Circuit, HUD99060KIT / Dri-Tech with 78” Infant Circuit Kit, HUD99001KIT / Single Limb Infant Circuit Dri-Tech Kit, HUD99009KIT / Dri-Tech with 60” Infant Circuit Kit, HUD99018KIT / Dri-Tech with 44” Infant Circuit Kit, HUD870NKIT / Dri-Tech Infant Accessory Bag, HUD1631 / Infant Wye Connector with Swivel)
K253322 · Medline Industries, LP · Mar 2026
Heated Breathing Tube
K243244 · Guangdong Eda Technology Co., Ltd. · Jul 2025
Thermalite Heated CPAP Tube (CTUBH06H15DS-2, CTUBH15-DS)
K241268 · Exceleron Medical · Aug 2024
Hudson RCI Dri-Tech Breathing Circuits
K234032 · Medline Industries, LP · Jun 2024
VentStar Helix dual heated (N) Plus (MP02650), VentStar Helix heated (N) Plus (MP02608)
K222822 · Draegerwerk AG & CO Kgaa · Jun 2023
Sunset Heated CPAP Tube
K201418 · Sunset Healthcare Solutions, Inc. · Jan 2021