Nebulo 28 Nebulizer Kit
FDA 510(k) K841158 · Inspiron Corp.
510(k) numberK841158
Submission
- Device name
- Nebulo 28 Nebulizer Kit
- Applicant
- Inspiron Corp.
Mchenry, IL, US - Received
- March 19, 1984
- Decision date
- March 30, 1984
- 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 |
|---|---|---|
| K860838 | Inspiron Double Swivel Trach AdapterBZA · Traditional | 04/09/1986SE |
| K850346 | Oxygen ConcentratorCAW · Traditional | 02/04/1985SE |
| K843932 | Vapor-Phase Humidifier Sys-AdvancedBTT · Traditional | 10/18/1984SE |
| K840935 | Manual Resuscitation SystemBTM · Traditional | 04/05/1984SE |
| K840418 | Inspiratory/Expiratory Muscle ExercisBWF · Traditional | 02/17/1984SE |
| K834290 | Inspiron Liquid Oxygen SystemBYJ · Traditional | 02/04/1984SE |
| K772072 | Manifold & Nebu. for Doub. Line Mach.CAF · Traditional | 11/15/1977SE |
| K772071 | Manifold & Nebu. for Single Line Mach.CAF · Traditional | 11/15/1977SE |
| K772070 | Ventilator Setup, VolumeCAF · Traditional | 11/15/1977SE |
| K772069 | Vol. Ventilator Setup W/Out NebulizerBZO · Traditional | 11/15/1977SE |
Questions and answers
When was Nebulo 28 Nebulizer Kit cleared by the FDA?
Nebulo 28 Nebulizer Kit (K841158) received a 510(k) decision of Substantially Equivalent on March 30, 1984, 11 days after the submission was received.
What is the product code of K841158?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.