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FDA 510(k)

inspired™ VHB20 Heated Humidifier

K-Number: K222351 · 2022-12-21

ApplicantVincent Healthcare Products Limited
Decision Date2022-12-21
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

inspired™ VHB20 Heated Humidifier is the device name listed in this FDA 510(k) record. The listed applicant is Vincent Healthcare Products Limited. It received FDA 510(k) clearance on 2022-12-21 under 510(k) number K222351. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the inspired™ VHB20 Heated Humidifier?

inspired™ VHB20 Heated Humidifier is a medical device that received FDA 510(k) clearance on 2022-12-21. The listed applicant is Vincent Healthcare Products Limited. The 510(k) number is K222351.

When did inspired™ VHB20 Heated Humidifier receive FDA 510(k) clearance?

inspired™ VHB20 Heated Humidifier received FDA 510(k) clearance on 2022-12-21, under 510(k) number K222351.

Who is the listed applicant for inspired™ VHB20 Heated Humidifier?

The FDA 510(k) record lists Vincent Healthcare Products Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for inspired™ VHB20 Heated Humidifier?

The FDA product code for inspired™ VHB20 Heated Humidifier is BTT.

Other records listing Vincent Healthcare Products Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252066inspired™ Heated Breathing Circuit (510-008); inspired™ Heated Breathing Circuit (510-009); inspired™ Auto-feed Humidification Chamber (VHC10); inspired™ Auto-feed Humidification Chamber (VHC20)

Related Devices (Code: BTT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254078HVT 2.0Vapotherm, Inc.K251448FL-10000U Respiratory HumidifierFlexicare Medical Limited.K251419Laboratorios Biogalenic Sterile Water for Inhalation, USPLaboratorios Biogalenic S.A. DE C.V.K253479Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)Fisher & Paykel Healthcare, Ltd.K250312Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra SmallMedline Industries, LPK251611Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944); Optiflow+ Nasal Cannula - Large (OPT946); Optiflow+ Nasal Cannula Small (MYOPT9SMALL); Optiflow+ Nasal Cannula Medium (MYOPT9MEDIUM); Optiflow+ Nasal Cannula Large (MYOPT9LARGE)Fisher & Paykel Healthcare, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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