Cleared Traditional

K092576 - GEM HEART ONE/ONE+

K092576 is an FDA 510(k) clearance for GEM HEART ONE/ONE+, manufactured by Gem-Med S.L.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K092576 · Gem-Med S.L. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
14d
Days
Class 2
Risk

K092576 is an FDA 510(k) clearance for the GEM HEART ONE/ONE+. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Gem-Med S.L. (Barcelona, ES). The FDA issued a Cleared decision on September 4, 2009 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Gem-Med S.L. devices

FDA 510(k) Submission Details - K092576

510(k) Number K092576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 2009
Decision Date September 04, 2009
Days to Decision 14 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 125d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 336
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K092576.
ELI PC ELECTROCARDIOGRAPH
K093339 · Mortara Instrument, Inc. · Feb 2010
ELI 350 ELECTROCARDIOGRAPH
K092663 · Mortara Instrument, Inc. · Dec 2009
PC ECG, MODEL SE-1010
K092010 · Edan Instruments, Inc. · Oct 2009
SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200
K091513 · Edan Instruments, Inc. · Jul 2009
SE-601 SERIES ELECTROCARDIOGRAPH
K090367 · Edan Instruments, Inc. · Jun 2009
SURSIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VS3 VITAL SIGNS MONITOR, SURESIGNS VM SERIES PATIENT MONITORS
K090483 · Philips Medical Systems · Mar 2009