Cleared Traditional

K952164 - EMI MODEL FFF-IA

K952164 is an FDA 510(k) clearance for EMI MODEL FFF-IA, manufactured by New York Heart Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DQK cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K952164 · New York Heart Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
7d
Days
Class 2
Risk

K952164 is an FDA 510(k) clearance for the EMI MODEL FFF-IA. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by New York Heart Instruments, Inc. (New York, US). The FDA issued a Cleared decision on May 10, 1995 after a review of 7 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all New York Heart Instruments, Inc. devices

FDA 510(k) Submission Details - K952164

510(k) Number K952164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 1995
Decision Date May 10, 1995
Days to Decision 7 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 125d · This submission: 7d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQK Device Classification - Class 2, Special Controls

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQK Computer, Diagnostic, Programmable

All 379
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K952164.
OMEGA CARES SYSTEM
K945068 · J-F Medical Systems Intl., Inc. · Jan 1996
HOLTER 6000
K950988 · Omega Medical Services, Inc. · Jan 1996
EPICARDIA
K952846 · Medicomp, Inc. · Sep 1995
INTERGRATED MONITORING ARCHIVING AND COMMUNICATIONS SYSTEMS (IMACS)
K941762 · Hogan & Hartson · Feb 1995
ALTAIR-DISC RECORDER
K942565 · Burdick Corp. · Dec 1994
DUALTHERM(R) CARDIAC OUTPUT COMPUTER
K925285 · B. Braun of America, Inc. · Jul 1993