Porous Media Humidiflow Humidifier for Universal Humidification
FDA 510(k) K062091 · Porous Media Corp.
510(k) numberK062091
Submission
- Device name
- Porous Media Humidiflow Humidifier for Universal Humidification
- Applicant
- Porous Media Corp.
St. Paul, MN, US - Received
- July 24, 2006
- Decision date
- August 8, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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 |
|---|---|---|
| K061426 | Oxygen Concentrator Filters, Models DBF32, DBF24, DBF27, DBF25, DFC06 and DDF47CAH · Traditional | 06/05/2006SE |
| K990276 | Porous Media DPB30 Series Disposable Pre-Bypass FilterKRJ · Traditional | 10/01/1999SE |
| K982385 | Porous Media DPB20 Series Disposable Pre-Bypass FilterKRJ · Traditional | 02/01/1999SE |
| K982127 | Porous Media DEF25 Disposable Respiratory FilterCAH · Special | 06/23/1998SE |
| K965020 | Porous Media DBF23 Reusable Respiratory FilterCAH · Traditional | 03/14/1997SE |
| K964979 | Porous Media DBF23 Disposable Respiratory FilterCAH · Traditional | 03/11/1997SE |
| K952428 | Porous Media DBF23-R Reusable Respiratory FilterCAH · Traditional | 07/07/1995SE |
| K934132 | Porous Media DBF23 Disposable Respiratory FilterCAH · Traditional | 10/04/1994SE |
Questions and answers
When was Porous Media Humidiflow Humidifier for Universal Humidification cleared by the FDA?
Porous Media Humidiflow Humidifier for Universal Humidification (K062091) received a 510(k) decision of Substantially Equivalent on August 8, 2006, 15 days after the submission was received.
What is the product code of K062091?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.