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PSG Cable C

by SenTec AG

PSG Cable C is a Class II device made by SenTec AG, cleared under FDA 510(k) K151329 on 17 Dec 2015 (3 earlier submissions) and listed in FDA GUDID since 12 Nov 2018 (UDI-DI 07640121880636), active as of 12 Nov 2026. 14 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07640121880636 UDI-DI Date12 Nov 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK151329 Date17 Dec 2015IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K151329 decided 17 Dec 2015 Active· +3 more in the status table
  • FDA GUDID UDI-DI 07640121880636 listed 12 Nov 2018 Listed

Recalls

14 recalls · 2 ongoing · FDA

    • 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.

    • Ongoing Z-1980-2023 FDA Class II initiated 2 May 2023

    The sensors may experience an out-of-box failure because after recalibration, the sensors stayed in the software mode "production" and were not reset to "released" mode.

    • 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-2155-2019 FDA Class II initiated 2 May 2019
    • Terminated Z-2153-2019 FDA Class II initiated 2 May 2019
    • Terminated Z-2152-2019 FDA Class II initiated 2 May 2019
    • Terminated Z-2156-2019 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).

    • Terminated Z-1501-2015 FDA Class II initiated 25 Mar 2015

    SenTec is voluntarily replacing V-Sign Sensors 2 due to pre-mature deterioration of a part of the PCO2 measuring unit and thus disabling PCO2-monitoring. This means that the affected sensors reach their end-of-life earlier than normally expected requiring the sensor`s replacement. There is no increased risk for the patient or operator, because the aforementioned deterioration results in the sens

  • 2 recalls, same reason

    • Terminated Z-0434-2013 FDA Class II initiated 5 Nov 2012
    • Terminated Z-0433-2013 FDA Class II initiated 5 Nov 2012

    A manufacturing defect was observed for the membrane changer insert that does not allow electrolyte to be present under the new membrane. The PCO2 performance of a sensor without electrolyte will be deteriorated.

    • Terminated Z-2199-2012 FDA Class II initiated 9 Jul 2012

    SenTec is recalling a number of V-Sign"2 Sensors due to a problem regarding configuration parameter writing during manufacturing.

Timeline

19 dated events

  1. Listed FDA GUDID 07640121880636
  2. Recall initiated FDA recalls Z-2154-2019
  3. Recall initiated FDA recalls Z-2155-2019
  4. Recall initiated FDA recalls Z-2153-2019
  5. Recall initiated FDA recalls Z-2152-2019
  6. Recall initiated FDA recalls Z-2156-2019
  7. Recall initiated FDA recalls Z-1134-2021
  8. Recall initiated FDA recalls Z-0148-2023
  9. Recall initiated FDA recalls Z-1980-2023
  10. Recall initiated FDA recalls Z-2592-2023

9 earlier events are in the sections above.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Pulse Co-oximeter probe, reusable
Model / reference
PSG Cable C
Primary DI / UDI-DI
07640121880636
510(k) Number
FDA product code
LPP, LKD, KLK, DQA, DPZ
GMDN term
Pulse Co-oximeter probe, reusable
Device class
Class II
Regulation number
868.2500, 868.2480, 870.2700, 870.2710
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pulse Co-oximeter probe, reusableTranscutaneous blood gas monitor sensorTranscutaneous blood gas monitoring system

Cleared under the same submission (K041548)

and 8 more cleared under K041548

Cleared under the same submission (K071672)

and 8 more cleared under K071672

Other devices from SenTec AG

See all devices from SenTec AG →

Properties

  • Prescription use
Other properties (14, all answered No)