510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K922757Substantially Equivalent

Sps 1550 Single Needle Patient System

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

K922757 is the FDA 510(k) clearance record for SPS 1550 SINGLE NEEDLE PATIENT SYSTEM, a class II device, cleared for Baxter Healthcare Corp on under FDA product code FKP (System, Dialysate Delivery, Single Patient). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K922757.

Clearance record

Decision date
Received
(979 days to decision)
Product code
FKP System, Dialysate Delivery, Single Patient
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Baxter Healthcare Corp 1620 Waulkegan Rd., Mcgaw Park IL
510(k) summary
Statement
Third party review
No

Clearances, product code FKP

Trailing 12 months

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

FDA records show no clearances under product code FKP in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FKP, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260