Cleared Traditional

K844896 - DEL MAR AVIONICS 8300 SECTOR IMAGER SYS

K844896 is an FDA 510(k) clearance for DEL MAR AVIONICS 8300 SECTOR IMAGER SYS, manufactured by Del Mar Avionics. The device is a Class 2 Cardiovascular device with product code DXK cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K844896 · Del Mar Avionics · Cardiovascular device
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Jun 1985
Decision
175d
Days
Class 2
Risk

K844896 is an FDA 510(k) clearance for the DEL MAR AVIONICS 8300 SECTOR IMAGER SYS. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Del Mar Avionics (Irvine, US). The FDA issued a Cleared decision on June 10, 1985 after a review of 175 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K844896

510(k) Number K844896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1984
Decision Date June 10, 1985
Days to Decision 175 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
50d slower than avg
Panel avg: 125d · This submission: 175d
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 77
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K844896.
750 SD ULTRASOUND SCANNER(MODIFICATION)
K851901 · Ultrasonix, Inc. · Oct 1985
KONTRON SIGMA ISC ECHOCARDIOGRAPH SYSTEM
K852543 · Kontron Instruments, Inc. · Sep 1985
ACCUCOM CARDIAC OUTPUT MONITOR
K851426 · Lawrence Medical Systems, Inc. · Jul 1985
COLOR DOPPLER 880
K843643 · Irex Corp. · Jan 1985
CARDIOSCAN - TM BEING APPLIED FOR
K841263 · Interspec, Inc. · Oct 1984
M-MODE ANALYSIS SYSTEM
K822425 · User Resources, Inc. · Oct 1982
K844896 · DEL MAR AVIONICS 8300 SECTOR IMAGER SYS
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