Staysite Adhesive

• EUDAMED Basic UDI-DI 764012188SA-MAR6E registered 11 Nov 2021 Active
• FDA 510(k) K151329 decided 17 Dec 2015 Active

• • Ongoing Z-2592-2023 FDA Class II ·initiated 25 Jul 2023

  During rework of components during the manufacturing process, an additional piece of material may have been left in the device, which may result in an impact on measurement performance.

• • Terminated Z-0148-2023 FDA Class II ·initiated 22 Aug 2022

  Weak skin adhesion.

• • Terminated Z-1134-2021 FDA Class II ·initiated 10 Dec 2020

  Device requires the use of an Isolation Transformer in combination with the SDM in home care settings to comply with applicable safety standards.

• 5 recalls, same reason

  • Terminated Z-2154-2019 FDA Class II ·initiated 2 May 2019
  • Terminated Z-2156-2019 FDA Class II ·initiated 2 May 2019
  • Terminated Z-2152-2019 FDA Class II ·initiated 2 May 2019
  • Terminated Z-2155-2019 FDA Class II ·initiated 2 May 2019
  • Terminated Z-2153-2019 FDA Class II ·initiated 2 May 2019

  There is an increased chance (approx. 5%) of no electrolyte or a reduced amount of electrolyte being applied to the sensor during the membrane change procedure.

• • Terminated Z-0088-2017 FDA Class II ·initiated 15 Sep 2016

  Sentec AG found that with one batch of an internal SenTec Monitor component (Docking Station Module) there is a risk that a fastening screw could become loose under certain circumstances. A loose screw within the monitor can create uncontrolled electrical connections, including short circuits, with the risk of smolder or fire and electrical shock (patient and/or operator).

1. 15 Sep 2016 Recall initiated FDA recalls Z-0088-2017
2. 2 May 2019 Recall initiated FDA recalls Z-2154-2019
3. 2 May 2019 Recall initiated FDA recalls Z-2156-2019
4. 2 May 2019 Recall initiated FDA recalls Z-2152-2019
5. 2 May 2019 Recall initiated FDA recalls Z-2155-2019
6. 2 May 2019 Recall initiated FDA recalls Z-2153-2019
7. 10 Dec 2020 Recall initiated FDA recalls Z-1134-2021
8. 11 Nov 2021 Registered EUDAMED 764012188SA-MAR6E
9. 22 Aug 2022 Recall initiated FDA recalls Z-0148-2023
10. 25 Jul 2023 Recall initiated FDA recalls Z-2592-2023

1 earlier event are in the sections above.

Model / reference

SA-MAR

Primary DI / UDI-DI

17640121880565, 27640121880562

Basic UDI-DI

764012188SA-MAR6E

510(k) Number

K151329 ↗

FDA product code

LKD

EMDN code

Z1203020405 Transcutaneous po2/pco2 monitors

Device class

Class I EUDAMED

Class II 510(k)

Regulation

21 CFR Part 868.2480

EU registration type

Standard device

EU market of registration

Germany

Advisory committee

Anesthesiology

FDA decision

SESE Substantially Equivalent

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA 510(k)). EU and US classes are different schemes, so this is not a disagreement.

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Source: 510k-lineage (choiben314), CC BY 4.0

EUDAMED SRN

CH-MF-000008058

Authorised representative

Sentec GmbH DE-AR-000007618

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