IC-2A MRI Adult/Pediatric Ventilator
FDA 510(k) K896380 · Bio-Med Devices, Inc.
510(k) numberK896380
Submission
- Device name
- IC-2A MRI Adult/Pediatric Ventilator
- Applicant
- Bio-Med Devices, Inc.
Madison, CT, US - Received
- November 6, 1989
- Decision date
- February 12, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CBK – Ventilator, Continuous, Facility Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code CBK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253647 | Evita (V800); Evita (V600)CBK · Traditional | Draegerwerk AG & CO Kgaa | 05/07/2026SE |
| K252663 | Inbentus VersatileCBK · Traditional | Iconic Solutions by Murcia, SL | 04/14/2026SE |
| K251888 | VPAP Pediatric Face MaskCBK · Traditional | Hsiner Co., Ltd. | 03/12/2026SE |
| K232365 | Vivo 45 LSCBK · Traditional | Oconnell Regulatory Consultants, Inc. | 12/19/2025SE |
| K252173 | F&P OptiNIV Hospital Vented Full Face Mask Compatible with Single-limb Circuits Size A…CBK · Traditional | Fisher & Paykel Healthcare, Ltd. | 09/10/2025SE |
| K243767 | SV600, SV800 VentilatorCBK · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 08/28/2025SE |
| K251133 | AVEA disposable expiratory filter/water trap (11790)CBK · Traditional | Telesair, Inc. | 05/08/2025SE |
| K243394 | AF531 Oro-Nasal SE Face MaskCBK · Traditional | Respironics, Inc. | 12/30/2024SE |
| K233486 | 731 Series VentilatorCBK · Traditional | ZOLL Medical Corporation | 12/13/2024SE |
| K223120 | Ventoux VC2; Ventoux VC3CBK · Traditional | Flight Medical Innovations , Ltd. | 12/02/2024SE |
More from Flight Medical Innovations , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K213948 | OxyMinderCCL · Traditional | 03/17/2022SE |
| K173973 | TV-100CBK · Traditional | 07/20/2018SE |
| K942938 | CROSSVENT-4 VentilatorCBK · Traditional | 09/19/1995ST |
| K896381 | MVP-10 MRI Infant VentilatorCBK · Traditional | 02/12/1990SE |
| K873614 | CBG Cuff ManometerBSK · Traditional | 01/22/1988SE |
| K871337 | M-2 Oxygen/Temperature MonitorCCL · Traditional | 06/05/1987SE |
| K871336 | M-1 Pressure MonitorCAP · Traditional | 06/05/1987SE |
| K871139 | M-10 Ventilation MonitorCAP · Traditional | 04/21/1987SE |
| K830230 | Programmable VentilatorCBK · Traditional | 02/09/1983SE |
| K823861 | ET-3 Emergency Transport VentilatorCBK · Traditional | 02/07/1983SE |
Questions and answers
When was IC-2A MRI Adult/Pediatric Ventilator cleared by the FDA?
IC-2A MRI Adult/Pediatric Ventilator (K896380) received a 510(k) decision of Substantially Equivalent on February 12, 1990, 98 days after the submission was received.
What is the product code of K896380?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.