FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40
FDA 510(k) K160665 · Maquet Critical Care AB
510(k) numberK160665
Submission
- Device name
- FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40
- Applicant
- Maquet Critical Care AB
Solna, SE - Received
- March 9, 2016
- Decision date
- March 29, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BSZ – Gas-Machine, Anesthesia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5160
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
Other 510(k)s with product code BSZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253330 | A5 Anesthesia System (A5); A7 Anesthesia System (A7)BSZ · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 06/25/2026SE |
| K252746 | Atlan (A100); Atlan (A100 XL); Atlan(A350); Atlan (A350 XL)BSZ · Traditional | Drägerwerk AG Co. Kgaa | 05/21/2026SE |
| K251352 | Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i…BSZ · Traditional | Codonics.Incorporated | 07/11/2025SE |
| K230931 | AtlanBSZ · Traditional | Drägerwerk AG Co. Kgaa | 07/23/2023SE |
| K213867 | Carestation 750/750cBSZ · Traditional | Datex-Ohmeda, Inc. | 03/28/2023SE |
| K201957 | A8, A9 Anesthesia SystemBSZ · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 03/26/2021SE |
| K191027 | Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemBSZ · Traditional | Maquet Critical Care AB | 03/18/2020SE |
| K171311 | A5 Anesthesia SystemBSZ · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 01/12/2018SE |
| K171292 | A7 Anesthesia SystemBSZ · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 01/12/2018SE |
| K172045 | Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire…BSZ · Traditional | Datex-Ohmeda, Inc. | 11/03/2017SE |
More from Datex-Ohmeda, Inc.
| 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 |
| K180098 | SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1CBK · Traditional | 03/19/2019SE |
| 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 FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 cleared by the FDA?
FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 (K160665) received a 510(k) decision of Substantially Equivalent on March 29, 2017, 385 days after the submission was received.
What is the product code of K160665?
The FDA product code is BSZ – Gas-Machine, Anesthesia, a Class II (moderate risk) device regulated under 21 CFR 868.5160.