510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K952164Substantially Equivalent

Emi Model Fff-Ia

New York Heart Instruments, Inc., New York NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952164 is the FDA 510(k) clearance record for EMI MODEL FFF-IA, a class II device, cleared for New York Heart Instruments, Inc. on under FDA product code DQK (Computer, Diagnostic, Programmable). FDA records list one 510(k) clearance for New York Heart Instruments, Inc. As of , FDA records show no recalls naming K952164.

Clearance record

Decision date
Received
(7 days to decision)
Product code
DQK Computer, Diagnostic, Programmable
Regulation
21 CFR 870.1425
Device class
Class II
Review panel
Cardiovascular
Applicant
New York Heart Instruments, Inc. C/O Bass & Ullman, Counsel Law, New York NY
510(k) summary
Statement
Third party review
No

Clearances, product code DQK

Trailing 12 months
26 clearances under product code DQK in the twelve months to October 2026, February 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code DQK, trailing twelve months
MonthClearances
November 20250
December 20254
January 20262
February 20265
March 20260
April 20263
May 20261
June 20263
July 20264
August 20262
September 20261
October 20261