Maxi-Miser Humidifier Insert 1020 & 1021
FDA 510(k) K842794 · Nova-Ventrx
510(k) numberK842794
Submission
- Device name
- Maxi-Miser Humidifier Insert 1020 & 1021
- Applicant
- Nova-Ventrx
Mchenry, IL, US - Received
- July 17, 1984
- Decision date
- October 4, 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
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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
| 510(k) | Device | Decision |
|---|---|---|
| K952267 | Criterion, Criterion I.V., ModifiedBZE · Traditional | 12/02/1997SE |
| K954480 | Condensate Collection KitCAI · Traditional | 12/29/1995SE |
| K893760 | Criterion I.V. Ventilator Breathing Circuit #1004BZO · Traditional | 08/10/1989SE |
| K881207 | Res-Q 1, 2, 3, 4 and 5BTM · Traditional | 08/15/1988SE |
| K870382 | DRV Disp Resuscit 3000/BAG Adapt 3010 & 3011CBP · Traditional | 03/06/1987SE |
| K863756 | Modified Criterion Ventilator Breathing CircuitBZO · Traditional | 11/13/1986SE |
| K850600 | Co-Ax Ventilator CircuitBZO · Traditional | 05/02/1985SE |
| K842795 | Maxi-Miser Humidifier Insert 1030BTT · Traditional | 10/04/1984SE |
| K841571 | Maxi-Miser Water Transfer Set 1021/1022 · Traditional | 05/30/1984SE |
| K841569 | Maxi-Miser Humidifier Insert 1020 · Traditional | 05/30/1984SE |
Questions and answers
When was Maxi-Miser Humidifier Insert 1020 & 1021 cleared by the FDA?
Maxi-Miser Humidifier Insert 1020 & 1021 (K842794) received a 510(k) decision of Substantially Equivalent on October 4, 1984, 79 days after the submission was received.
What is the product code of K842794?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.