Heated Respiratory Humififier MR440

Q: What is the product code of K850647?

The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.

FDA 510(k) K850647 · Fisher & Paykel Allied Products , Ltd.

Substantially Equivalent

510(k) numberK850647

Submission

Device name: Heated Respiratory Humififier MR440
Applicant: Fisher & Paykel Allied Products , Ltd.
Auckland, New Zealand, NZ
Received: February 19, 1985
Decision date: March 12, 1985
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code: BTT – Humidifier, Respiratory Gas, (Direct Patient Interface)
Device class: Class II (moderate risk)
Regulation: 21 CFR 868.5450
Specialty: Anesthesiology

Other 510(k)s with product code BTT

510(k)	Device	Applicant	Decision
K262268	Optiflow Oxygen Kit (AA484J)BTT · Special	Fisher and Paykel Healthcare Limited	08/27/2026SE
K254078	HVT 2.0BTT · Traditional	Vapotherm, Inc.	04/13/2026SE
K251448	FL-10000U Respiratory HumidifierBTT · Traditional	Flexicare Medical Limited.	01/16/2026SE
K251419	Laboratorios Biogalenic Sterile Water for Inhalation, USPBTT · Traditional	Laboratorios Biogalenic S.A. DE C.V.	01/14/2026SE
K253479	Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)BTT · Special	Fisher & Paykel Healthcare, Ltd.	12/19/2025SE
K250312	Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…BTT · Traditional	Medline Industries, LP	07/02/2025SE
K251611	Optiflow+ Nasal Cannula - Small (OPT942); Optiflow+ Nasal Cannula - Medium (OPT944)…BTT · Special	Fisher & Paykel Healthcare, Ltd.	06/25/2025SE
K242717	Laboratorios Biogalenic Sterile Water for Inhalation, USPBTT · Traditional	Laboratorios Biogalenic S.A. DE C.V.	01/30/2025SE
K241778	Hudson RCI Comfort Flo® CubCannulaBTT · Traditional	Medline Industries, LP	12/19/2024SE
K240163	Hudson RCI® Comfort Flo Nasal Cannula; Hudson RCI® Comfort Flo Plus CannulaBTT · Traditional	Medline Industries, LP	09/27/2024SE

More from Medline Industries, LP

510(k)	Device	Decision
K880702	Model MR430 Special Purpose Humid. Heater BasesBTT · Traditional	07/08/1988SE
K872138	MR630 Enhanced Dual Servo Heater HumidifierBTT · Traditional	10/07/1987SE
K872139	MR420 Transport HumidifierBTT · Traditional	09/15/1987SE
K863377	MR338 Servo Heated Delivery HumidifierBTT · Traditional	02/20/1987SE
K870055	MR590 Dual Hose Heater Power PackBTT · Traditional	02/10/1987SE
K862923	MR620 Dual Servo Heated Anaesthesia HumidifierBTT · Traditional	09/23/1986SE
K852962	Peripheral Nerve Stimulator Model A400BXN · Traditional	12/09/1985SE
K851879	Heated Respiratory HumidifierBTT · Traditional	09/03/1985SE
K843903	Heated Respiratory Humidifier MR428BTT · Traditional	10/22/1984SE
K832928	Servo Heated Respiratory HumidifierBTT · Traditional	11/25/1983SE

Questions and answers

When was Heated Respiratory Humififier MR440 cleared by the FDA?

Heated Respiratory Humififier MR440 (K850647) received a 510(k) decision of Substantially Equivalent on March 12, 1985, 21 days after the submission was received.

What is the product code of K850647?

The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.