510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863609Substantially Equivalent

Single-Patient Automatic Dialysis Unit Mod. Dbb-22

International Medical Products, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863609 is the FDA 510(k) clearance record for SINGLE-PATIENT AUTOMATIC DIALYSIS UNIT MOD. DBB-22, a class II device, cleared for International Medical Products, Inc. on under FDA product code FKP (System, Dialysate Delivery, Single Patient). FDA records list 10 510(k) clearances for International Medical Products, Inc., from to . As of , FDA records show no recalls naming K863609.

Clearance record

Decision date
Received
(162 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
International Medical Products, Inc. 4503 Moorland Ave., Minneapolis MN
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FKP, 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