731 Series Ventilator
FDA 510(k) K233486 · ZOLL Medical Corporation
510(k) numberK233486
Submission
- Device name
- 731 Series Ventilator
- Applicant
- ZOLL Medical Corporation
Chelsmford, MA, US - Received
- October 27, 2023
- Decision date
- December 13, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
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|---|---|---|---|
| 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 |
| K223120 | Ventoux VC2; Ventoux VC3CBK · Traditional | Flight Medical Innovations , Ltd. | 12/02/2024SE |
| K241135 | RESPOND(R) VentilatorCBK · Traditional | Corvent Medical, Inc. | 11/13/2024SE |
More from Corvent Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K202375 | ZOLL Propaq MMWI · Traditional | 03/09/2021SE |
| K180482 | ZOLL Propaq MMHX · Traditional | 11/30/2018SE |
| K172653 | Power InfuserFRN · Traditional | 07/18/2018SE |
| K162832 | 731 Series VentilatorsCBK · Traditional | 08/02/2017SE |
| K170533 | Model 330 Multifunction AspiratorBTA · Traditional | 04/18/2017SE |
| K142915 | ZOLL X SeriesMKJ · Traditional | 12/03/2014SE |
| K141774 | Zoll X SeriesMKJ · Traditional | 11/19/2014SE |
| K140502 | Zoll E Series AlsLDD · Traditional | 11/06/2014SE |
| K133484 | Zoll X SeriesMKJ · Traditional | 08/01/2014SE |
| K132488 | Zoll Code WriterDXJ · Traditional | 04/03/2014SE |
Questions and answers
When was 731 Series Ventilator cleared by the FDA?
731 Series Ventilator (K233486) received a 510(k) decision of Substantially Equivalent on December 13, 2024, 413 days after the submission was received.
What is the product code of K233486?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.