510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163388Substantially Equivalent

XPress BCD Breast Compression Device

Xpress BCD LLC, Frederick MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163388 is the FDA 510(k) clearance record for XPress BCD Breast Compression Device, a class II device, cleared for Xpress Bcd, LLC on under FDA product code POY (Post Breast Biopsy Hemostatic Breast Compression Device). FDA's definition for product code POY reads: "To achieve and maintain hemostasis of a breast biopsy wound site". FDA records list one 510(k) clearance for Xpress Bcd, LLC. As of , FDA records show no recalls naming K163388.

Clearance record

Decision date
Received
(229 days to decision)
Product code
POY Post Breast Biopsy Hemostatic Breast Compression Device
Regulation
21 CFR 892.1710
Device class
Class II
Review panel
Radiology
Applicant
Xpress Bcd, LLC 6024 White Flint Dr., Frederick MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code POY

Trailing 12 months

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

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