Servo Guard
FDA 510(k) K182862 · Maquet Critical Care AB
510(k) numberK182862
Submission
- Device name
- Servo Guard
- Applicant
- Maquet Critical Care AB
Solna, SE - Received
- October 11, 2018
- Decision date
- October 21, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAH – Filter, Bacterial, Breathing-Circuit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5260
- Specialty
- Anesthesiology
Other 510(k)s with product code CAH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252643 | Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledCAH · Traditional | Teleflex Medical Sdn. Bhd. | 05/15/2026SE |
| K251583 | Ambu® Virobac II® Exhalation FilterCAH · Traditional | Ambu A/S | 04/30/2026SE |
| K241339 | Besmed Bacterial Filter and HMEFCAH · Traditional | Besmed Health Business Corp | 11/14/2024SE |
| K222917 | Breathing circuit bacterial/viral filterCAH · Traditional | Shaoxing Haitech Medical Products Co., Ltd. | 02/15/2024SE |
| K230483 | Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)CAH · Traditional | Passy-Muir, Inc. | 09/16/2023SE |
| K223258 | TNI Clear-Guard 3 angled breathing filter (1545020)CAH · Traditional | Intersurgical , Ltd. | 06/15/2023SE |
| K221472 | Filter and HME/FilterCAH · Traditional | Ningbo Huakun Medical Equipment Co., Ltd. | 02/08/2023SE |
| K221836 | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusCAH · Traditional | Drägerwerk AG & Co. KGaA | 12/07/2022SE |
| K221250 | EasyOne FilterCAH · Traditional | Ndd Medizintechnik AG | 11/22/2022SE |
| K210352 | GGM Breathing Circuit Bacterial FilterCAH · Traditional | Great Group Medical Co, Ltd. | 03/27/2022SE |
More from Great Group Medical Co, 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 |
| K180098 | SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1CBK · Traditional | 03/19/2019SE |
| 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 Guard cleared by the FDA?
Servo Guard (K182862) received a 510(k) decision of Substantially Equivalent on October 21, 2019, 375 days after the submission was received.
What is the product code of K182862?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.