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FDA 510(k)

AirSpiral Heated Breathing Tube

K-Number: K162553 · 2018-12-20

ApplicantFisher & Paykel Healthcare
Decision Date2018-12-20
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

AirSpiral Heated Breathing Tube is the device name listed in this FDA 510(k) record. The listed applicant is Fisher & Paykel Healthcare. It received FDA 510(k) clearance on 2018-12-20 under 510(k) number K162553. 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 AirSpiral Heated Breathing Tube?

AirSpiral Heated Breathing Tube is a medical device that received FDA 510(k) clearance on 2018-12-20. The listed applicant is Fisher & Paykel Healthcare. The 510(k) number is K162553.

When did AirSpiral Heated Breathing Tube receive FDA 510(k) clearance?

AirSpiral Heated Breathing Tube received FDA 510(k) clearance on 2018-12-20, under 510(k) number K162553.

Who is the listed applicant for AirSpiral Heated Breathing Tube?

The FDA 510(k) record lists Fisher & Paykel Healthcare as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AirSpiral Heated Breathing Tube?

The FDA product code for AirSpiral Heated Breathing Tube is BTT.

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Other records listing Fisher & Paykel Healthcare 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.

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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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