510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901015Substantially Equivalent

Wright Pocket Dopplers Vascular & Obstetric

Wright Medical, Kirkland WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901015 is the FDA 510(k) clearance record for WRIGHT POCKET DOPPLERS VASCULAR & OBSTETRIC, a class II device, cleared for Wright Medical Corp. on under FDA product code DPW (Flowmeter, Blood, Cardiovascular). FDA records list 6 510(k) clearances for Wright Medical Corp., from to . As of , FDA records show no recalls naming K901015.

Clearance record

Decision date
Received
(245 days to decision)
Product code
DPW Flowmeter, Blood, Cardiovascular
Regulation
21 CFR 870.2100
Device class
Class II
Review panel
Cardiovascular
Applicant
Wright Medical Corp. 11023 118th Pl. NE, Kirkland WA
Third party review
No

Clearances, product code DPW

Trailing 12 months
3 clearances under product code DPW in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DPW, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260