510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K870722Substantially Equivalent

Label Chg for Erika Model 9608 Arterial Blood Line

National Medical Care, Medical Products Div., Inc., Rockleigh NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870722 is the FDA 510(k) clearance record for LABEL CHG FOR ERIKA MODEL 9608 ARTERIAL BLOOD LINE, a class II device, cleared for National Medical Care, Medical Products Div., Inc. on under FDA product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve). FDA records list 62 510(k) clearances for National Medical Care, Medical Products Div., Inc., from to . As of , FDA records show no recalls naming K870722.

Clearance record

Decision date
Received
(587 days to decision)
Product code
FJK Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
National Medical Care, Medical Products Div., Inc. Two Volvo Dr., Rockleigh NJ
Third party review
No

Clearances, product code FJK

Trailing 12 months
2 clearances under product code FJK in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code FJK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260