Cleared Traditional

K822389 - LIFE TRACE 40/42

K822389 is an FDA 510(k) clearance for LIFE TRACE 40/42, 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 43-day FDA review.

K822389 · Life Science Instrumentation, Inc. · Cardiovascular device
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Sep 1982
Decision
43d
Days
Class 2
Risk

K822389 is an FDA 510(k) clearance for the LIFE TRACE 40/42. 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 September 21, 1982 after a review of 43 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 - K822389

510(k) Number K822389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1982
Decision Date September 21, 1982
Days to Decision 43 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
82d faster than avg
Panel avg: 125d · This submission: 43d
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 K822389.
CADIO-RESPIRATORY MONITOR #CR-2
K823312 · Electromed Intl., Ltd. · Nov 1982
MODEL 78534A PATIENT MONITOR
K822876 · Hewlett-Packard Co. · Oct 1982
SIGNAL DISTRIBUTION NETWORK #78581A
K822695 · Hewlett-Packard Co. · Oct 1982
LIFE TRACE 24
K822390 · Life Science Instrumentation, Inc. · Sep 1982
LIFE WATCH LSI
K822615 · Life Science Instrumentation, Inc. · Sep 1982
LIFE TRACE 14
K822388 · Life Science Instrumentation, Inc. · Aug 1982