SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1
FDA 510(k) K180098 · Maquet Critical Care AB
510(k) numberK180098
Submission
- Device name
- SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1
- Applicant
- Maquet Critical Care AB
Solna, SE - Received
- January 16, 2018
- Decision date
- March 19, 2019
- 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 |
| 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 |
|---|---|---|
| K253715 | Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi…PIF · Traditional | 08/26/2026SE |
| K230173 | Servo-air Lite Ventilator SystemMNT · Traditional | 07/06/2023SE |
| K201874 | Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator…CBK · Traditional | 04/20/2021SE |
| K191027 | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemBSZ · Traditional | 03/18/2020SE |
| K182862 | Servo GuardCAH · Traditional | 10/21/2019SE |
| K160665 | FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40BSZ · Abbreviated | 03/29/2017SE |
| K153688 | Edi Catheter ENFitPIF · Traditional | 03/02/2017SE |
| K151814 | SERVO-U Ventilator System, SERVO-n Ventilator SystemCBK · Traditional | 12/21/2015SE |
| K153461 | Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire…KNT · Special | 12/11/2015SE |
| K123149 | Servo-I Ventilator SystemCBK · Abbreviated | 06/20/2014SE |
Questions and answers
When was SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 cleared by the FDA?
SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 (K180098) received a 510(k) decision of Substantially Equivalent on March 19, 2019, 427 days after the submission was received.
What is the product code of K180098?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.