Cleared Traditional

K821942 - HARVEY-BOSTWICK BRADY CARDIA MONIT. HB85

K821942 is an FDA 510(k) clearance for HARVEY-BOSTWICK BRADY CARDIA MONIT. HB85, manufactured by Harvey-Bostwick, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K821942 · Harvey-Bostwick, Inc. · Cardiovascular device
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Aug 1982
Decision
56d
Days
Class 2
Risk

K821942 is an FDA 510(k) clearance for the HARVEY-BOSTWICK BRADY CARDIA MONIT. HB85. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Harvey-Bostwick, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 24, 1982 after a review of 56 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 Harvey-Bostwick, Inc. devices

FDA 510(k) Submission Details - K821942

510(k) Number K821942 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1982
Decision Date August 24, 1982
Days to Decision 56 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 125d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRT Device Classification - Class 2, Special Controls

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 229
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K821942.
LIFE TRACE 40/42
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LIFE TRACE 24
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LIFE TRACE 14
K822388 · Life Science Instrumentation, Inc. · Aug 1982
CARDIO-RESPIRATORY MONITOR MODEL CR-1
K821959 · Electromed Intl., Ltd. · Jul 1982
TELCOR 2
K821755 · Burdick Corp. · Jul 1982