510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K932408Substantially Equivalent

Ambulatory Infusion Pump System and Solution Sets

Baxter Healthcare Corporation, Round Lake IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K932408 is the FDA 510(k) clearance record for AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETS, a class I device, cleared for Baxter Healthcare Corp on under FDA product code FFN (Clamp, Non-Electrical). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K932408.

Clearance record

Decision date
Received
(133 days to decision)
Product code
FFN Clamp, Non-Electrical
Regulation
21 CFR 876.4730
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
Baxter Healthcare Corp Rte. 120 And Wilson Rd., Round Lake IL
510(k) summary
Summary
Third party review
No

Clearances, product code FFN

Trailing 12 months

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

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