Humidifier Adapter
FDA 510(k) K962079 · Automatic Liquid Packaging, Inc.
510(k) numberK962079
Submission
- Device name
- Humidifier Adapter
- Applicant
- Automatic Liquid Packaging, Inc.
Woodstock, IL, US - Received
- May 28, 1996
- Decision date
- July 31, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K994321 | Sterile Water and 0.9% Sodium Chloride for Irrigation, UspJOL · Traditional | 10/25/2000SE |
| K000964 | Sterile Water or O.9% Sodium Chloride, Model AL4100 & AL4109JOH · Special | 04/25/2000SE |
| K980147 | Your Choice Multi-Purpose Contact Lens Cleaning SolutionLPN · Traditional | 04/13/1998SE |
| K973829 | Irrigation BottleJOH · Traditional | 02/23/1998SE |
| K955104 | High Flow Adjustable Entrainment NebulizerCAF · Traditional | 06/11/1996SE |
| K920306 | Opti-Mol Filtered Puncture PinBTT · Traditional | 04/06/1992SE |
| K911770 | Optimol Respiratory Humidification SystemBTT · Traditional | 10/15/1991SE |
| K901762 | Prefilled Flexible R.T. Containers W/Ster. SodiumBTT · Traditional | 07/17/1990SE |
| K901362 | Accessory Fitment to Nebulizer System, SterileCAF · Traditional | 06/06/1990SE |
| K901301 | Ster Inhal Solut Prefil BTL W/Adjust Entrain NebulCAF · Traditional | 05/31/1990SE |
Questions and answers
When was Humidifier Adapter cleared by the FDA?
Humidifier Adapter (K962079) received a 510(k) decision of Substantially Equivalent on July 31, 1996, 64 days after the submission was received.
What is the product code of K962079?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.