510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K822551Substantially Equivalent

Amp Capd Unispike Aministration Set

American Medical Products LLC, Freehold NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822551 is the FDA 510(k) clearance record for AMP CAPD UNISPIKE AMINISTRATION SET, a class I device, cleared for American Medical Products, Inc. on under FDA product code FKK (Clamp, Line). FDA records list 30 510(k) clearances for American Medical Products, Inc., from to . As of , FDA records show no recalls naming K822551.

Clearance record

Decision date
Received
(50 days to decision)
Product code
FKK Clamp, Line
Regulation
21 CFR 876.4730
Device class
Class I
Review panel
Gastroenterology, Urology
Applicant
American Medical Products, Inc. Po Drawer 190, Freehold NJ
Third party review
No

Clearances, product code FKK

Trailing 12 months

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

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