Modified 225/SIMV Volume Ventilator
FDA 510(k) K884389 · Monaghan Medical Corp.
510(k) numberK884389
Submission
- Device name
- Modified 225/SIMV Volume Ventilator
- Applicant
- Monaghan Medical Corp.
Plattsburgh, NY, US - Received
- October 18, 1988
- Decision date
- March 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 |
|---|---|---|
| K220145 | Monaghan medical filtered mouthpiece kitCAF · Traditional | 08/24/2023SE |
| K123945 | Strive Dual Zone Peak Flow MeterBZH · Traditional | 04/17/2013SE |
| K110273 | Aerovent Plus CHCCAF · Traditional | 06/09/2011SE |
| K031514 | Modification to Trupeak Peak Flow MeterBZH · Special | 05/23/2003SE |
| K023097 | Truezone Peak Flow MeterBZH · Abbreviated | 03/07/2003SE |
| K012939 | Aerovent II CHC Collapsible Holding ChamberCAF · Special | 09/28/2001SE |
| K991212 | Modification to Truzone Peak Flow MeterBZH · Abbreviated | 07/01/1999SE |
| K964130 | Aerogear Asthma Action KitBZH · Traditional | 01/10/1997SE |
| K963089 | Truzone Peak Flow MeterBZH · Traditional | 11/06/1996SE |
| K963095 | Trupeak Peak Flow MeterBZH · Traditional | 11/04/1996SE |
Questions and answers
When was Modified 225/SIMV Volume Ventilator cleared by the FDA?
Modified 225/SIMV Volume Ventilator (K884389) received a 510(k) decision of Substantially Equivalent on March 12, 1990, 510 days after the submission was received.
What is the product code of K884389?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.