Cleared Traditional

TELCOR 2 (K821755) - FDA 510(k) Clearance

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

K821755 · Burdick Corp. · Cardiovascular device

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Jul 1982

Decision

17d

Days

Class 2

Risk

K821755 is an FDA 510(k) clearance for the TELCOR 2. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Burdick Corp. (Walker, US). The FDA issued a Cleared decision on July 2, 1982 after a review of 17 days - a notably fast clearance cycle.

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: 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 Burdick Corp. devices

Submission Details

510(k) Number	K821755 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 15, 1982
Decision Date	July 02, 1982
Days to Decision	17 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

108d faster than avg

Panel avg: 125d · This submission: 17d

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 68

Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K821755.

NEUROMEDICS PACETRON HEART RATE MONITOR

K823290 · Intermedics, Inc. · Dec 1982

MODEL 78534A PATIENT MONITOR

K822876 · Hewlett-Packard Co. · Oct 1982

SIGNAL DISTRIBUTION NETWORK #78581A

K822695 · Hewlett-Packard Co. · Oct 1982

MODELS 78504A & 78508A PATIENT MON. SYS

K821368 · Hewlett-Packard Co. · May 1982

CARDIAC MONITOR - RATE ALARM

K820825 · Hewlett-Packard Co. · Apr 1982

#505 PORT. VITAL FUNCTIONS NEONATAL MON

K820416 · Ge Medical Systems Information Technologies · Mar 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 K821755

Burdick Corp.

Walker, MI · US

Regulatory profile

38 submissions 38 cleared

100% 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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