Airlife Bubble Humidifer, Model 002003 and 002006
FDA 510(k) K991484 · Allegiance Healthcare Corp.
510(k) numberK991484
Submission
- Device name
- Airlife Bubble Humidifer, Model 002003 and 002006
- Applicant
- Allegiance Healthcare Corp.
Mcgraw Park, IL, US - Received
- April 28, 1999
- Decision date
- May 13, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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
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| K251448 | FL-10000U Respiratory HumidifierBTT · Traditional | Flexicare Medical Limited. | 01/16/2026SE |
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| K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…BTT · Traditional | Medline Industries, LP | 07/02/2025SE |
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| 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 |
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| K024292 | Modification to Positive Touch Powder-Free Latex Examination Gloves with Protein and…LYY · Special | 01/09/2003SE |
| K024102 | Dental Powder-Free Latex Examination Gloves with Protein Labeling ClaimLYY · Special | 12/18/2002SE |
| K023425 | Drapes with Absorbent ReinforcementKKX · Special | 11/06/2002SE |
| K022765 | Nitrile Powder-Free Examination GlovesLZA · Traditional | 10/11/2002SE |
| K023170 | Nitrile Powder-Free Examination GlovesLZA · Special | 10/09/2002SE |
| K023167 | Breathable Surgical GownFYA · Special | 10/02/2002SE |
Questions and answers
When was Airlife Bubble Humidifer, Model 002003 and 002006 cleared by the FDA?
Airlife Bubble Humidifer, Model 002003 and 002006 (K991484) received a 510(k) decision of Substantially Equivalent on May 13, 1999, 15 days after the submission was received.
What is the product code of K991484?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.