510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K111854Substantially Equivalent

Ao Usb Receiver, Wi-Box, Wi-Box Psu Kit, Wi-Box Xpress Cable, Pw Usb Receiver

St. Jude Medical Systems AB, Uppsala, SE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111854 is the FDA 510(k) clearance record for AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER, a class II device, cleared for St. Jude Medical Systems AB on under FDA product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency). FDA records list 5 510(k) clearances for St. Jude Medical Systems AB, from to . As of , FDA records show no recalls naming K111854.

Clearance record

Decision date
Received
(114 days to decision)
Product code
DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Regulation
21 CFR 870.2910
Device class
Class II
Review panel
Cardiovascular
Applicant
St. Jude Medical Systems AB Palmbladsgatan 10, Uppsala, SE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRG

Trailing 12 months
2 clearances under product code DRG in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260