510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131253Substantially Equivalent

Periflux 6000

Perimed AB, Jarfalla, SE / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131253 is the FDA 510(k) clearance record for PERIFLUX 6000, a class II device, cleared for Perimed AB on under FDA product code LKD (Monitor, Carbon-Dioxide, Cutaneous). FDA records list 10 510(k) clearances for Perimed AB, from to . As of , FDA records show no recalls naming K131253.

Clearance record

Decision date
Received
(173 days to decision)
Product code
LKD Monitor, Carbon-Dioxide, Cutaneous
Regulation
21 CFR 868.2480
Device class
Class II
Review panel
Anesthesiology
Applicant
Perimed AB Datavagen 9a, Jarfalla, SE
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