Lo-Comp RESERVOIR-RE-1000
FDA 510(k) K831163 · Cygnus Research Corp.
510(k) numberK831163
Submission
- Device name
- Lo-Comp RESERVOIR-RE-1000
- Applicant
- Cygnus Research Corp.
Mchenry, IL, US - Received
- April 11, 1983
- Decision date
- May 3, 1983
- 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
| 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 |
|---|---|---|
| K831556 | Vapor-Phase Humidifier SystemBTT · Traditional | 07/19/1983SE |
| K830923 | Temp-Check Adaptor, Straight ConfiguraBZO · Traditional | 05/03/1983SE |
| K830922 | Temp-Check Adaptor, Tee-ConfigurationBZO · Traditional | 05/02/1983SE |
| K830921 | Temp-Check Adaptor, Y-ConfigurationBZO · Traditional | 05/02/1983SE |
Questions and answers
When was Lo-Comp RESERVOIR-RE-1000 cleared by the FDA?
Lo-Comp RESERVOIR-RE-1000 (K831163) received a 510(k) decision of Substantially Equivalent on May 3, 1983, 22 days after the submission was received.
What is the product code of K831163?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.