Cleared Traditional

K920099 - GYMMAN

K920099 is an FDA 510(k) clearance for GYMMAN, manufactured by Lumiscope Co., Inc.. The device is a Class 2 Cardiovascular device with product code DRT cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K920099 · Lumiscope Co., Inc. · Cardiovascular device
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Mar 1992
Decision
60d
Days
Class 2
Risk

K920099 is an FDA 510(k) clearance for the GYMMAN. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Lumiscope Co., Inc. (Edison, US). The FDA issued a Cleared decision on March 9, 1992 after a review of 60 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 Lumiscope Co., Inc. devices

FDA 510(k) Submission Details - K920099

510(k) Number K920099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 1992
Decision Date March 09, 1992
Days to Decision 60 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 125d · This submission: 60d
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 213
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K920099.
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MODEL 556 MONITOR W/24-HR. TREND RECALL/MODIFIED
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SYSTEM ATHENA - PRODUCT ENHANCEMENTS
K912049 · S & W Medico Teknik · Dec 1991
DATASCOPE PASSPORT MONITOR
K911598 · Datascope Corp. · Oct 1991