A Quapak
FDA 510(k) K811073 · Respiratory Care, Inc.
510(k) numberK811073
Submission
- Device name
- A Quapak
- Applicant
- Respiratory Care, Inc.
Mchenry, IL, US - Received
- April 20, 1981
- Decision date
- April 29, 1981
- 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 |
|---|---|---|
| K892230 | Rci Viral/Bacterial FilterCAH · Traditional | 08/28/1989SE |
| K884150 | Modified Conchatherm III Controlled HeaterBTT · Traditional | 11/21/1988SE |
| K881625 | Conchatherm III Plus Dual Heat Wire Servo ControllBZE · Traditional | 06/21/1988SE |
| K864147 | AquavalveBYH · Traditional | 12/05/1986SE |
| K863955 | Colby Level AlarmBTT · Traditional | 11/07/1986SE |
| K861555 | Circapak Universal Volume Ventilator CircuitBZD · Traditional | 06/05/1986SE |
| K834151 | Conchatherm LHF Humidifier HeaterBTT · Traditional | 01/13/1984SE |
| K833974 | Aquapak 020 Humidifier AdapterBTT · Traditional | 12/16/1983SE |
| K832453 | Slimb Single Limb Breathing CircuitCAI · Traditional | 10/27/1983SE |
| K811524 | AquacadeLHC · Traditional | 07/01/1981SE |
Questions and answers
When was A Quapak cleared by the FDA?
A Quapak (K811073) received a 510(k) decision of Substantially Equivalent on April 29, 1981, 9 days after the submission was received.
What is the product code of K811073?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.