Cleared Traditional

BARTRONIX IN-BED ACTIVITY MONITOR (K914859) - FDA 510(k) Clearance

Class I General Hospital device.

K914859 · Bartronix · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1992
Decision
167d
Days
Class 1
Risk

K914859 is an FDA 510(k) clearance for the BARTRONIX IN-BED ACTIVITY MONITOR. Classified as Monitor, Bed Patient (product code KMI), Class I - General Controls.

Submitted by Bartronix (Fort Worth, US). The FDA issued a Cleared decision on April 13, 1992 after a review of 167 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.2400 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Bartronix devices

Submission Details

510(k) Number K914859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1991
Decision Date April 13, 1992
Days to Decision 167 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
38d slower than avg
Panel avg: 129d · This submission: 167d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KMI Monitor, Bed Patient
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.2400
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.