Cleared Traditional

K761211 - MODEL 15050A DIGITAL DISPLAY

K761211 is the FDA 510(k) clearance for MODEL 15050A DIGITAL DISPLAY by Hewlett-Packard Co.. It is a Class 2 Cardiovascular device (product code DRT) cleared through the Traditional 510(k) pathway after a 6-day FDA review.

K761211 · Hewlett-Packard Co. · Cardiovascular device
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Dec 1976
Decision
6d
Days
Class 2
Risk

K761211 is an FDA 510(k) clearance for the MODEL 15050A DIGITAL DISPLAY. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Mchenry, US). The FDA issued a Cleared decision on December 13, 1976 after a review of 6 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 Hewlett-Packard Co. devices

Submission Details

510(k) Number K761211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1976
Decision Date December 13, 1976
Days to Decision 6 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
119d faster than avg
Panel avg: 125d · This submission: 6d
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 154
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K761211.
DIGITAL HEART RATE METER
K770239 · Burdick Corp. · Feb 1977
MONITOR, HEARTWATCH HEART RATE
K770038 · Respironics, Inc. · Jan 1977
CENTRAL STATION MONITORING SYSTEM
K761291 · Abbott Laboratories · Dec 1976
PHYSIOLOGICAL MONITOR (MODEL 870)
K760803 · Datascope Corp. · Oct 1976
PORTABLE CARDIAC MONITOR, ABBY
K760593 · Abbott Laboratories · Sep 1976
PULSE CARDULE (MODEL 1859/1860 ECG)
K760120 · Spacelabs, Inc. · Jul 1976