510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K222112Substantially Equivalent

Comfort Marker 2.0

Medical Precision BV, Zwolle, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K222112 is the FDA 510(k) clearance record for Comfort Marker 2.0, a class II device, cleared for Medical Precision BV on under FDA product code QRN (Radiation Therapy Marking Device). FDA's definition for product code QRN reads: "A radiation therapy marking device is a powered device that transdermally delivers a permanent or temporary colorant to the skin for the purpose of placing marks to guide radiation therapy. This classification does not include devices with...". FDA records list 2 510(k) clearances for Medical Precision BV, from to . As of , FDA records show no recalls naming K222112.

Clearance record

Decision date
Received
(255 days to decision)
Product code
QRN Radiation Therapy Marking Device
Regulation
21 CFR 892.5785
Device class
Class II
Review panel
Radiology
Applicant
Medical Precision BV Telfordstraat 9-30, Zwolle, NL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QRN

Trailing 12 months

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

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