Cleared Traditional

K812828 - MODEL 2000 MONITOR

K812828 is the FDA 510(k) clearance for MODEL 2000 MONITOR by Datascope Corp.. It is a Class 2 Cardiovascular device (product code DRT) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K812828 · Datascope Corp. · Cardiovascular device
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Nov 1981
Decision
39d
Days
Class 2
Risk

K812828 is an FDA 510(k) clearance for the MODEL 2000 MONITOR. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Datascope Corp. (Mchenry, US). The FDA issued a Cleared decision on November 16, 1981 after a review of 39 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 Datascope Corp. devices

Submission Details

510(k) Number K812828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 08, 1981
Decision Date November 16, 1981
Days to Decision 39 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
86d faster than avg
Panel avg: 125d · This submission: 39d
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 115
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K812828.
#505 PORT. VITAL FUNCTIONS NEONATAL MON
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K820417 · Ge Medical Systems Information Technologies · Mar 1982
NIHON KOHDEN HEART MONITORS OMP 7101-02
K813444 · Nihon Kohden America, Inc. · Dec 1981
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K811893 · Novametrix Medical Systems, Inc. · Sep 1981
CENTRAL STATION MONITOR
K812271 · Datascope Corp. · Aug 1981
RESIDENT BEDSIDE MONITOR
K811216 · Abbott Laboratories · Jul 1981