510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001866Substantially Equivalent

Tcm400

Radiometer Medical ApS, Bronshoj, DK / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K001866 is the FDA 510(k) clearance record for TCM400, a class II device, cleared for Radiometer Medical A/S on under FDA product code LPP (Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia). FDA records list 30 510(k) clearances for Radiometer Medical A/S, from to . As of , FDA records show 3 recalls naming K001866.

Clearance record

Decision date
Received
(170 days to decision)
Product code
LPP Monitor, Oxygen, Cutaneous, For Uses Other Than For Infant Not Under Gas Anesthesia
Regulation
21 CFR 868.2500
Device class
Class II
Review panel
Anesthesiology
Applicant
Radiometer Medical A/S Akandevej 21 Dk-2700, Bronshoj, DK
510(k) summary
Summary
Third party review
No

Clearances, product code LPP

Trailing 12 months

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

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