510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830197Substantially Equivalent

Transcutaneous Blood Oxygen Sensor Sys

Diamond Shamrock Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830197 is the FDA 510(k) clearance record for TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS, a class II device, cleared for Diamond Shamrock Corp. on under FDA product code KLK (Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia). FDA records list 2 510(k) clearances for Diamond Shamrock Corp., from to . As of , FDA records show no recalls naming K830197.

Clearance record

Decision date
Received
(313 days to decision)
Product code
KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Regulation
21 CFR 868.2500
Device class
Class II
Review panel
Anesthesiology
Applicant
Diamond Shamrock Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code KLK

Trailing 12 months

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

FDA records show no clearances under product code KLK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KLK, 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