510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K963203Substantially Equivalent

Bentley Quick-Prime Hemoconcentrator with Duraflo Treatment

Baxter Healthcare Corporation, Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963203 is the FDA 510(k) clearance record for BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT, a class II device, cleared for Baxter Healthcare Corp on under FDA product code KDI (Dialyzer, High Permeability With Or Without Sealed Dialysate System). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K963203.

Clearance record

Decision date
Received
(222 days to decision)
Product code
KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System
Regulation
21 CFR 876.5860
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Baxter Healthcare Corp 17221 Red Hill Ave., Santa Ana CA
510(k) summary
Summary
Third party review
No

Clearances, product code KDI

Trailing 12 months
7 clearances under product code KDI 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 KDI, trailing twelve months
MonthClearances
December 20251
January 20261
February 20261
March 20261
April 20260
May 20261
June 20260
July 20261
August 20260
September 20260
October 20261
November 20260