510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K802289Substantially Equivalent

Pericardiocentesis Kit

Stanco Medical, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802289 is the FDA 510(k) clearance record for PERICARDIOCENTESIS KIT, a class II device, cleared for Stanco Medical, Inc. on under FDA product code DOR (Radioimmunoassay, Digoxin (3-H), Bovine Antibody, Charcoal Sep.). FDA records list 19 510(k) clearances for Stanco Medical, Inc., from to . As of , FDA records show no recalls naming K802289.

Clearance record

Decision date
Received
(68 days to decision)
Product code
DOR Radioimmunoassay, Digoxin (3-H), Bovine Antibody, Charcoal Sep.
Regulation
21 CFR 862.3320
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Stanco Medical, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DOR

Trailing 12 months

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

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