HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010
FDA 510(k) K152029 · Hamilton Medical AG
510(k) numberK152029
Submission
- Device name
- HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010
- Applicant
- Hamilton Medical AG
Bonaduz, CH - Received
- July 22, 2015
- Decision date
- May 3, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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 |
|---|---|---|
| K201306 | HAMILTON-C3CBK · Traditional | 02/05/2021SE |
| K201658 | Hamilton-C6CBK · Traditional | 12/11/2020SE |
| K193228 | Hamilton-G5CBK · Traditional | 05/04/2020SE |
| K181216 | HAMILTON-T1, HAMILTON-C1CBK · Traditional | 08/02/2019SE |
| K163283 | HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010BTT · Traditional | 09/20/2017SE |
| K161450 | HAMILTON-C3CBK · Traditional | 04/27/2017SE |
| K153046 | HAMILTON-MR1CBK · Traditional | 09/06/2016SE |
| K150893 | IntelliCuffBSK · Traditional | 01/29/2016SE |
| K140939 | HAMILTON-T1,HAMILTON-C1CBK · Traditional | 09/02/2015SE |
| K122438 | HAMILTON-MR1CBK · Abbreviated | 11/20/2013SE |
Questions and answers
When was HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 cleared by the FDA?
HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 (K152029) received a 510(k) decision of Substantially Equivalent on May 3, 2016, 286 days after the submission was received.
What is the product code of K152029?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.