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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
510(k) Number K252066
Device Name inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit (510-009); inspired™ Auto-feed Humidification Chamber (VHC10); inspired™ Auto-feed Humidification Chamber (VHC20)
Applicant
Vincent Healthcare Products Limited
Rm.B2, 7/F Hang Fung Industrial Bldg., Phase 2
2g Hok Yuen St., Hung Hom
Kowloon,  HK
Applicant Contact Thomas Chan
Correspondent
ProMedic, LLC
131 Bay Pt. Dr. NE
St. Petersburg,  FL  33704
Correspondent Contact Paul Dryden
Regulation Number868.5270
Classification Product Code
BZE  
Date Received07/01/2025
Decision Date 06/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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