Model MR430 Special Purpose Humid. Heater Bases
FDA 510(k) K880702 · Fisher & Paykel Allied Products , Ltd.
510(k) numberK880702
Submission
- Device name
- Model MR430 Special Purpose Humid. Heater Bases
- Applicant
- Fisher & Paykel Allied Products , Ltd.
Auckland, New Zealand, NZ - Received
- February 22, 1988
- Decision date
- July 8, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| 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 |
| K850647 | Heated Respiratory Humififier MR440BTT · Traditional | 03/12/1985SE |
| K843903 | Heated Respiratory Humidifier MR428BTT · Traditional | 10/22/1984SE |
| K832928 | Servo Heated Respiratory HumidifierBTT · Traditional | 11/25/1983SE |
Questions and answers
When was Model MR430 Special Purpose Humid. Heater Bases cleared by the FDA?
Model MR430 Special Purpose Humid. Heater Bases (K880702) received a 510(k) decision of Substantially Equivalent on July 8, 1988, 137 days after the submission was received.
What is the product code of K880702?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.