Cleared Traditional

K122285 - TABLET COMMANDER

K122285 is an FDA 510(k) clearance for TABLET COMMANDER, manufactured by Cardiocom, LLC. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K122285 · Cardiocom, LLC · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
15d
Days
Class 2
Risk

K122285 is an FDA 510(k) clearance for the TABLET COMMANDER. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Cardiocom, LLC (Chanhassan, US). The FDA issued a Cleared decision on August 14, 2012 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - 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 Cardiocom, LLC devices

FDA 510(k) Submission Details - K122285

510(k) Number K122285 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2012
Decision Date August 14, 2012
Days to Decision 15 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
110d faster than avg
Panel avg: 125d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

DRG Device Classification - Class 2, Special Controls

Product Code DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2910
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 Consultant

Regulatory Technology Services, LLC
MARK JOB

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

All 134
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K122285.
WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM
K123671 · Sanitas, Inc. · Jan 2013
REMOTE PRESENCE SYSTEM, MODEL RP-VITA
K123229 · Intouch Health, Inc. · Nov 2012
MOBILECARE MONITOR
K122333 · Aframe Digital, Inc. · Nov 2012
ICP TRIAGEMANAGER
K122095 · Emergo Europe Consulting BV · Jul 2012
CONNECTED CARE MOBILE APPLICATION
K120325 · Watermark Medical · Jul 2012
VIGNET TELEHEALTH MANAGER
K113446 · Vignet, Inc. · Jul 2012