510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K925469Substantially Equivalent

Jj Skinner Carekits(tm) Dialysis On/off Kit

J.J. Skinner, Inc., Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K925469 is the FDA 510(k) clearance record for JJ SKINNER CAREKITS(TM) DIALYSIS ON/OFF KIT, a class I device, cleared for J.J. Skinner, Inc. on under FDA product code FKG (Tray, Start/Stop (Including Contents), Dialysis). FDA records list 7 510(k) clearances for J.J. Skinner, Inc., from to . As of , FDA records show no recalls naming K925469.

Clearance record

Decision date
Received
(916 days to decision)
Product code
FKG Tray, Start/Stop (Including Contents), Dialysis
Regulation
21 CFR 876.5820
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
J.J. Skinner, Inc. C/O Medical Device Inspection, Great Neck NY
510(k) summary
Statement
Third party review
No

Clearances, product code FKG

Trailing 12 months

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

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