Cleared Traditional

K781535 - AC ADAPTER:MODELS 9525,9526,9527

K781535 is an FDA 510(k) clearance for AC ADAPTER:MODELS 9525, manufactured by Edwards Laboratories. The device is a Class 2 Cardiovascular device with product code DXG cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K781535 · Edwards Laboratories · Cardiovascular device
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Sep 1978
Decision
9d
Days
Class 2
Risk

K781535 is an FDA 510(k) clearance for the AC ADAPTER:MODELS 9525,9526,9527. Classified as Computer, Diagnostic, Pre-programmed, Single-function (product code DXG), Class II - Special Controls.

Submitted by Edwards Laboratories (Mchenry, US). The FDA issued a Cleared decision on September 15, 1978 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1435 - 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 Edwards Laboratories devices

FDA 510(k) Submission Details - K781535

510(k) Number K781535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 06, 1978
Decision Date September 15, 1978
Days to Decision 9 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
116d faster than avg
Panel avg: 125d · This submission: 9d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXG Device Classification - Class 2, Special Controls

Product Code DXG Computer, Diagnostic, Pre-programmed, Single-function
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1435
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 - DXG Computer, Diagnostic, Pre-programmed, Single-function

All 117
Devices cleared under the same product code (DXG) and FDA review panel - the closest regulatory comparables to K781535.
MODEL 656 ARRHYTHMIA ANALYZER
K792080 · Del Mar Avionics · Dec 1979
STORAGE, DIGITAL DSC-1, CONTROL UNIT
K790288 · Oxford Medilog, Inc. · Feb 1979
LVV OPTION
K781855 · Honeywell, Inc. · Jan 1979
CENTRAL MONITORING SYSTEM
K772152 · Burdick Corp. · Nov 1977
LIGHT-PEN SYSTEM FOR QUANTI. ANALY.
K772158 · Varian Assoc., Inc. · Nov 1977
CARDIAC OUTPUT THERMODILUTION MODULE
K771991 · Abbott Laboratories · Nov 1977