510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K151329Substantially Equivalent

SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet

Sentec AG, Therwil, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K151329 is the FDA 510(k) clearance record for SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet, a class II device, cleared for Sentec AG on under FDA product code LKD (Monitor, Carbon-Dioxide, Cutaneous). FDA records list 7 510(k) clearances for Sentec AG, from to . As of , FDA records show 9 recalls naming K151329.

Clearance record

Decision date
Received
(213 days to decision)
Product code
LKD Monitor, Carbon-Dioxide, Cutaneous
Regulation
21 CFR 868.2480
Device class
Class II
Review panel
Anesthesiology
Applicant
Sentec AG Ringstrasse 39, Therwil, CH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LKD

Trailing 12 months

FDA records hold no clearances under product code LKD in the trailing twelve months.

FDA records show no clearances under product code LKD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LKD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260