510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K121634Substantially Equivalent

Interlink System Extension Set with Control-a-Flo-Regulatory Clearlink System Extension Set with Control-a-Flo-Regulator

Baxter Healthcare Corporation, Round Lake IL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121634 is the FDA 510(k) clearance record for INTERLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATORY CLEARLINK SYSTEM EXTENSION SET WITH CONTROL-A-FLO-REGULATOR, a class II device, cleared for Baxter Healthcare Corporation on under FDA product code FPA (Set, Administration, Intravascular). FDA records list 570 510(k) clearances for Baxter Healthcare Corporation, from to . As of , FDA records show no recalls naming K121634.

Clearance record

Decision date
Received
(25 days to decision)
Product code
FPA Set, Administration, Intravascular
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Baxter Healthcare Corporation 25212 W. Illinois Rte. 120, Round Lake IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FPA

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