510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955887Substantially Equivalent

Newmed Abp-Lite

Newmed Inc, Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955887 is the FDA 510(k) clearance record for NEWMED ABP-LITE, a class II device, cleared for Newmed Corp. on under FDA product code DXW (System, Phonocatheter, Intracavitary). FDA records list 2 510(k) clearances for Newmed Corp., from to . As of , FDA records show no recalls naming K955887.

Clearance record

Decision date
Received
(252 days to decision)
Product code
DXW System, Phonocatheter, Intracavitary
Regulation
21 CFR 870.1270
Device class
Class II
Review panel
Cardiovascular
Applicant
Newmed Corp. 1575 Eye St. NW, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code DXW

Trailing 12 months

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

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