Cleared Traditional

K910029 - PATIENT CARE MANAGEMENT SYSTEM MODIFICATION

K910029 is an FDA 510(k) clearance for PATIENT CARE MANAGEMENT SYSTEM MODIFICATION, manufactured by Spacelabs, Inc.. The device is a Class 2 Cardiovascular device with product code DXK cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K910029 · Spacelabs, Inc. · Cardiovascular device
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Jan 1991
Decision
28d
Days
Class 2
Risk

K910029 is an FDA 510(k) clearance for the PATIENT CARE MANAGEMENT SYSTEM MODIFICATION. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Spacelabs, Inc. (Redmond, US). The FDA issued a Cleared decision on January 31, 1991 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2330 - 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 Spacelabs, Inc. devices

FDA 510(k) Submission Details - K910029

510(k) Number K910029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 1991
Decision Date January 31, 1991
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXK Device Classification - Class 2, Special Controls

Product Code DXK Echocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2330
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 - DXK Echocardiograph

All 40
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K910029.
Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)
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