510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K220527Substantially Equivalent

PADnet Xpress

Collaborative Care Diagnostics LLC dba BioMedix, Eagan MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K220527 is the FDA 510(k) clearance record for PADnet Xpress, a class II device, cleared for Collaborative Care Diagnostics, LLC, D.B.A. Biomedix on under FDA product code JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic). FDA records list one 510(k) clearance for Collaborative Care Diagnostics, LLC, D.B.A. Biomedix. As of , FDA records show no recalls naming K220527.

Clearance record

Decision date
Received
(238 days to decision)
Product code
JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Regulation
21 CFR 870.2780
Device class
Class II
Review panel
Cardiovascular
Applicant
Collaborative Care Diagnostics, LLC, D.B.A. Biomedix 860 Blue Gentian Rd., Eagan MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JOM

Trailing 12 months

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

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