Cleared Traditional

K821223 - CR-9

K821223 is an FDA 510(k) clearance for CR-9, manufactured by Life Science Instrumentation, Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K821223 · Life Science Instrumentation, Inc. · Cardiovascular device
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Jun 1982
Decision
51d
Days
Class 2
Risk

K821223 is an FDA 510(k) clearance for the CR-9. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Life Science Instrumentation, Inc. (Walker, US). The FDA issued a Cleared decision on June 17, 1982 after a review of 51 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 Life Science Instrumentation, Inc. devices

FDA 510(k) Submission Details - K821223

510(k) Number K821223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1982
Decision Date June 17, 1982
Days to Decision 51 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 125d · This submission: 51d
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 193
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K821223.
CARDIO-RESPIRATORY MONITOR MODEL CR-1
K821959 · Electromed Intl., Ltd. · Jul 1982
TELCOR 2
K821755 · Burdick Corp. · Jul 1982
PHYSIOLOGICAL DISPLAY SYSTEM, MODEL 1000
K821720 · Novametrix Medical Systems, Inc. · Jun 1982
MODELS 78504A & 78508A PATIENT MON. SYS
K821368 · Hewlett-Packard Co. · May 1982
CARDIAC MONITOR - RATE ALARM
K820825 · Hewlett-Packard Co. · Apr 1982
DIASCOPE 2
K820745 · Puritan Bennett Corp. · Apr 1982