East Autoclave Humidifier
FDA 510(k) K812957 · Cairco , Ltd.
510(k) numberK812957
Submission
- Device name
- East Autoclave Humidifier
- Applicant
- Cairco , Ltd.
Mchenry, IL, US - Received
- October 21, 1981
- Decision date
- March 12, 1982
- 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 |
|---|---|---|
| K812961 | Sheffield Infant Ventilator Mark 4CBK · Traditional | 03/26/1982SE |
| K812959 | Spirox aBZK · Traditional | 01/22/1982SE |
| K812956 | Spirox HBZK · Traditional | 01/22/1982SE |
| K812958 | East-Freeman Ventilator Mark 2CBK · Traditional | 01/07/1982SE |
| K812955 | East Water Unit Mark 3DWJ · Traditional | 12/29/1981SE |
| K812953 | Radcliffe Ventilator Mark 5CBK · Traditional | 11/27/1981SE |
| K812960 | East Ventilarm Pressure Monitor Alarm S.CAP · Traditional | 11/16/1981SE |
| K810640 | Polarised Light GroniometerKQX · Traditional | 04/17/1981SE |
Questions and answers
When was East Autoclave Humidifier cleared by the FDA?
East Autoclave Humidifier (K812957) received a 510(k) decision of Substantially Equivalent on March 12, 1982, 142 days after the submission was received.
What is the product code of K812957?
The FDA product code is BTT – Humidifier, Respiratory Gas, (Direct Patient Interface), a Class II (moderate risk) device regulated under 21 CFR 868.5450.