Cleared Traditional

K830916 - VITA/TRAC 4 FUNCTION VITAL SIGN MONITOR

K830916 is the FDA 510(k) clearance for VITA/TRAC 4 FUNCTION VITAL SIGN MONITOR by Bib, Inc.. It is a Class 2 Cardiovascular device (product code DRT) cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K830916 · Bib, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1983
Decision
107d
Days
Class 2
Risk

K830916 is an FDA 510(k) clearance for the VITA/TRAC 4 FUNCTION VITAL SIGN MONITOR. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Bib, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 7, 1983 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Bib, Inc. devices

Submission Details

510(k) Number K830916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1983
Decision Date July 07, 1983
Days to Decision 107 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 125d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 155
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K830916.
PATIENT MONITOR #78353A
K831787 · Hewlett-Packard Co. · Sep 1983
AIR SHIELDS AS-100 MONIORING SYS-AS105
K831430 · Narco Scientific · Sep 1983
PHYSIOLOGICAL MONITOR #902
K831578 · Novametrix Medical Systems, Inc. · Aug 1983
GOULD MODEL IM3000-IM3100 BATTERY POWER
K830885 · Gould, Inc. · Jun 1983
CENTRAL STATION DISPLAY/RECORDER MATRIX
K830517 · Marquette Electronics, Inc. · Jun 1983
VITAL SIGNS MONITOR 2
K830587 · Physio-Control Corp. · Jun 1983