510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801858Substantially Equivalent

Oxymeter & Transoxode

Thoracel, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801858 is the FDA 510(k) clearance record for OXYMETER & TRANSOXODE, a class I device, cleared for Thoracel on under FDA product code KLH (Antisera, C. Acnes). FDA records list one 510(k) clearance for Thoracel. As of , FDA records show no recalls naming K801858.

Clearance record

Decision date
Received
(9 days to decision)
Product code
KLH Antisera, C. Acnes
Regulation
21 CFR 866.3140
Device class
Class I
Review panel
Microbiology
Applicant
Thoracel 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code KLH

Trailing 12 months

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

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