Cleared Traditional

HEWLETT PACKARD MODEL 5650C, CARDIO DATA MGMT SYST (K905100) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K905100 · Hewlett-Packard Co. · Cardiovascular device
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Jan 1991
Decision
63d
Days
Class 2
Risk

K905100 is an FDA 510(k) clearance for the HEWLETT PACKARD MODEL 5650C, CARDIO DATA MGMT SYST. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Waltham, US). The FDA issued a Cleared decision on January 15, 1991 after a review of 63 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 K905100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1990
Decision Date January 15, 1991
Days to Decision 63 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
62d faster than avg
Panel avg: 125d · This submission: 63d
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 174
Devices cleared under the same product code (DQK) and FDA review panel - the closest regulatory comparables to K905100.
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PHYSIOLOGICAL MEASUREMENT AND DISPLAY SYSTEMS
K920587 · Siemens Medical Solutions USA, Inc. · Jan 1993
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K874171 · Hewlett-Packard Co. · Feb 1988
MICOR
K865010 · Siemens Medical Solutions USA, Inc. · Jul 1987