510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K213974Substantially Equivalent

GEM FLOW COUPLER Monitor (GEM1020M-2)

SYNOVIS MICRO COMPANIES ALLIANCE, Inc. (a subsidiary of Baxter International Inc.), Birmingham AL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213974 is the FDA 510(k) clearance record for GEM FLOW COUPLER Monitor (GEM1020M-2), a class II device, cleared for Synovis Micro Companies Alliance, Inc. on under FDA product code DPW (Flowmeter, Blood, Cardiovascular). FDA records list 5 510(k) clearances for SYNOVIS MICRO COMPANIES ALLIANCE, INC. (a subsidiary of Baxter International Inc.), from to . As of , FDA records show no recalls naming K213974.

Clearance record

Decision date
Received
(121 days to decision)
Product code
DPW Flowmeter, Blood, Cardiovascular
Regulation
21 CFR 870.2100
Device class
Class II
Review panel
Cardiovascular
Applicant
Synovis Micro Companies Alliance, Inc. (A Subsidiary Of Baxter International Inc.), Birmingham AL
510(k) summary
Summary PDF
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