Cleared Traditional

VITAL SIGNS MONITOR 2 (K830587) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K830587 · Physio-Control Corp. · Cardiovascular device

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Jun 1983

Decision

105d

Days

Class 2

Risk

K830587 is an FDA 510(k) clearance for the VITAL SIGNS MONITOR 2. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Physio-Control Corp.. The FDA issued a Cleared decision on June 8, 1983 after a review of 105 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 Physio-Control Corp. devices

Submission Details

510(k) Number	K830587 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 23, 1983
Decision Date	June 08, 1983
Days to Decision	105 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

20d faster than avg

Panel avg: 125d · This submission: 105d

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 74

Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K830587.

PATIENT MONITOR 788 33A

K831943 · Hewlett-Packard Co. · Oct 1983

PATIENT MONITOR #78832A

K831944 · Hewlett-Packard Co. · Oct 1983

PATIENT MONITOR #78353A

K831787 · Hewlett-Packard Co. · Sep 1983

MODEL 515 NEO-TRAK NEONATAL MONITOR

K823904 · Ge Medical Systems Information Technologies · May 1983

NEUROMEDICS PACETRON HEART RATE MONITOR

K823290 · Intermedics, Inc. · Dec 1982

MODEL 78534A PATIENT MONITOR

K822876 · Hewlett-Packard Co. · Oct 1982

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K830587

Physio-Control Corp.

, WA · US

Regulatory profile

80 submissions 78 cleared

98% clearance rate · Active in Cardiovascular

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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