Prefilled Humidifer
FDA 510(k) K810219 · Corpak Co.
510(k) numberK810219
Submission
- Device name
- Prefilled Humidifer
- Applicant
- Corpak Co.
Mchenry, IL, US - Received
- January 27, 1981
- Decision date
- March 4, 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
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| 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
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|---|---|---|
| K964514 | Corpak Medsystems Cruz Catheter for Peritoneal DialysisFKO · Traditional | 06/26/1998SE |
| K970178 | Clog Zapper Enteral Feeding Tube Declogging SystemKNT · Traditional | 07/21/1997SE |
| K935512 | Corpak Replacement Gastrostomy Device StomacoreKNT · Traditional | 08/29/1996SE |
| K944750 | Corflo 300 PumpFRN · Traditional | 06/19/1995PT |
| K931921 | Corpak Gastrostomy TubeKNT · Traditional | 06/09/1995SE |
| K932847 | Corpak Enteral PumpFRN · Traditional | 06/17/1994ST |
| K902949 | Corpak Grasping ForcepsOCZ · Traditional | 08/30/1990SE |
| K901501 | Corpak Gastrostomy TubeKGC · Traditional | 06/11/1990SE |
| K882867 | Corpak Percutaneous Endoscopic Gastrostomy TubeKNT · Traditional | 09/21/1988SE |
| K853253 | Corpak Farrell Valve Enteral Gastric Pressure ReliKNT · Traditional | 11/05/1985SE |
Questions and answers
When was Prefilled Humidifer cleared by the FDA?
Prefilled Humidifer (K810219) received a 510(k) decision of Substantially Equivalent on March 4, 1981, 36 days after the submission was received.
What is the product code of K810219?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.