Cleared Traditional

K780768 - MODEL 5621A INTERFACE

K780768 is the FDA 510(k) clearance for MODEL 5621A INTERFACE by Hewlett-Packard Co.. It is a Class 2 Cardiovascular device (product code DQK) cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K780768 · Hewlett-Packard Co. · Cardiovascular device
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May 1978
Decision
21d
Days
Class 2
Risk

K780768 is an FDA 510(k) clearance for the MODEL 5621A INTERFACE. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Mchenry, US). The FDA issued a Cleared decision on May 26, 1978 after a review of 21 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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 K780768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 1978
Decision Date May 26, 1978
Days to Decision 21 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
104d faster than avg
Panel avg: 125d · This submission: 21d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 - DQK Computer, Diagnostic, Programmable

All 259
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K780768.
DATABASE MANAGEMENT & REPORTING SYSTEM
K792677 · Honeywell, Inc. · Jan 1980
ARRHYTHMIA II EDITOR
K791776 · Spacelabs, Inc. · Oct 1979
QUINTON STATUS 1000
K782072 · Quinton, Inc. · Feb 1979
AUTOMATED PHYSIOLOGIC PROFILER
K780530 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1978
MEDDARS CARDIOVASCULAR DIAGNOSTIC SYSTEM
K760767 · Honeywell, Inc. · Oct 1976