Cleared Traditional

PILL PHONE (K060298) - FDA 510(k) Clearance

Class I General Hospital device.

K060298 · Vocel · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
51d
Days
Class 1
Risk

K060298 is an FDA 510(k) clearance for the PILL PHONE. Classified as Reminder, Medication (product code NXQ), Class I - General Controls.

Submitted by Vocel (Washington, US). The FDA issued a Cleared decision on March 29, 2006 after a review of 51 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 890.5050 - the FDA general hospital device 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 Vocel devices

Submission Details

510(k) Number K060298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2006
Decision Date March 29, 2006
Days to Decision 51 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 129d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code NXQ Reminder, Medication
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5050
Definition A Medication Reminder Is A Device Intended For Medical Purposes To Provide Alerts To Patients Or Healthcare Providers For Pre-determined Medication Dosing Schedules. The Device May Incorporate Wireless Communication.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.