510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823827Substantially Equivalent

Amp 80/2 Outflow Monitor Modification

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

K823827 is the FDA 510(k) clearance record for AMP 80/2 OUTFLOW MONITOR MODIFICATION, a class II device, cleared for American Medical Products, Inc. on under FDA product code FKX (System, Peritoneal, Automatic Delivery). FDA records list 30 510(k) clearances for American Medical Products, Inc., from to . As of , FDA records show no recalls naming K823827.

Clearance record

Decision date
Received
(87 days to decision)
Product code
FKX System, Peritoneal, Automatic Delivery
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
American Medical Products, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code FKX

Trailing 12 months

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

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