510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K090422Substantially Equivalent

Lucas 2

Jolife AB, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090422 is the FDA 510(k) clearance record for LUCAS 2, a class II device, cleared for Jolife AB on under FDA product code DRM (Compressor, Cardiac, External). FDA records list 5 510(k) clearances for Jolife AB, from to . As of , FDA records show 3 recalls naming K090422.

Clearance record

Decision date
Received
(119 days to decision)
Product code
DRM Compressor, Cardiac, External
Regulation
21 CFR 870.5200
Device class
Class II
Review panel
Cardiovascular
Applicant
Jolife AB 555 13th St., NW, Washington DC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRM

Trailing 12 months

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

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