Perseus A500
FDA 510(k) K133886 · Draeger Medical GmbH
510(k) numberK133886
Submission
- Device name
- Perseus A500
- Applicant
- Draeger Medical GmbH
Andover, MA, US - Received
- December 20, 2013
- Decision date
- June 20, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K121886 | Savina 300 Savina 300, Country VariantsCBK · Traditional | 08/08/2014SE |
| K121999 | General Purpose Temperature Probe, Skin Temperature ProbeFLL · Traditional | 02/28/2013SE |
| K103035 | Smartpilot View Model MK04500BSZ · Traditional | 03/28/2012SE |
| K102618 | Ventstar Heated, Infinity Id Breathing Circuit HeatedBTT · Traditional | 12/10/2010SE |
| K092029 | Ventstar Resuscitaire, Model MP00311, Ventstar Resuscitaire Ceu, Model MP00310BYE · Traditional | 08/06/2010SE |
| K100941 | Infinity Mcable - Mainstream CO2CCK · Special | 04/23/2010SE |
| K092999 | NBP CuffDXQ · Traditional | 11/24/2009SE |
| K083050 | Evite XLCBK · Special | 12/29/2008SE |
| K081447 | Fourth Gas Module with CO2 for Primus US ApolloBSZ · Traditional | 10/08/2008SE |
| K081743 | Classicstar NV Se and Novastar NV Se and Aav Full Face MasksCBK · Traditional | 09/22/2008SE |
Questions and answers
When was Perseus A500 cleared by the FDA?
Perseus A500 (K133886) received a 510(k) decision of Substantially Equivalent on June 20, 2014, 182 days after the submission was received.
What is the product code of K133886?
The FDA product code is BSZ – Gas-Machine, Anesthesia, a Class II (moderate risk) device regulated under 21 CFR 868.5160.