510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K001958Substantially Equivalent

Keystone Medical Schon Xl Soft-Line Double Lument Catheter. Keystone Medical 12 F Duo-Flow and 14F Duo-Flow 400 Xl Cath

Keystone Medical, Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001958 is the FDA 510(k) clearance record for KEYSTONE MEDICAL SCHON XL SOFT-LINE DOUBLE LUMENT CATHETER. KEYSTONE MEDICAL 12 F DUO-FLOW AND 14F DUO-FLOW 400 XL CATH, a class II device, cleared for Keystone Medical on under FDA product code MPB (Catheter, Hemodialysis, Non-Implanted). FDA records list 2 510(k) clearances for Keystone Medical, from to . As of , FDA records show no recalls naming K001958.

Clearance record

Decision date
Received
(90 days to decision)
Product code
MPB Catheter, Hemodialysis, Non-Implanted
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Keystone Medical 55 Northern Blvd., Suite 200, Great Neck NY
510(k) summary
Summary
Third party review
No

Clearances, product code MPB

Trailing 12 months

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

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