510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K882401Substantially Equivalent

Stony Brook Model Eecp-Mc1

Stony Brook Trading and Development Corp., Northport NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882401 is the FDA 510(k) clearance record for STONY BROOK MODEL EECP-MC1, a class II device, cleared for Stony Brook Trading and Development Corp. on under FDA product code DRN (Device, Counter-Pulsating, External). FDA records list one 510(k) clearance for Stony Brook Trading and Development Corp. As of , FDA records show no recalls naming K882401.

Clearance record

Decision date
Received
(266 days to decision)
Product code
DRN Device, Counter-Pulsating, External
Regulation
21 CFR 870.5225
Device class
Class II
Review panel
Cardiovascular
Applicant
Stony Brook Trading and Development Corp. 25 Asharoken Ave., Northport NY
Third party review
No

Clearances, product code DRN

Trailing 12 months
1 clearance under product code DRN in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260