Cleared Traditional

K903839 - INTERSPEC APOGEE

K903839 is an FDA 510(k) clearance for INTERSPEC APOGEE, manufactured by Interspec, Inc.. The device is a Class 2 Cardiovascular device with product code DXK cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K903839 · Interspec, Inc. · Cardiovascular device
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Nov 1990
Decision
87d
Days
Class 2
Risk

K903839 is an FDA 510(k) clearance for the INTERSPEC APOGEE. Classified as Echocardiograph (product code DXK), Class II - Special Controls.

Submitted by Interspec, Inc. (Ambler, US). The FDA issued a Cleared decision on November 16, 1990 after a review of 87 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 Interspec, Inc. devices

FDA 510(k) Submission Details - K903839

510(k) Number K903839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 21, 1990
Decision Date November 16, 1990
Days to Decision 87 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
38d faster than avg
Panel avg: 125d · This submission: 87d
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 46
Devices cleared under the same product code (DXK) and FDA review panel - the closest regulatory comparables to K903839.
ACCESSORY TO GENESIS III (GCFM)
K913209 · Biosound, Inc. · May 1992
MODIFIED SYST: SONOS 500/1000 ULTRSOUND IMAG SYST
K904832 · Hewlett-Packard Co. · Apr 1991
PATIENT CARE MANAGEMENT SYSTEM MODIFICATION
K910029 · Spacelabs, Inc. · Jan 1991
MODEL MD-5 DOPPLER
K901592 · D. E. Hokanson, Inc. · Oct 1990
ADD'L TRANSDUCER FOR USE W/EUB-565 ULTRASOUND
K901657 · Hitachi Medical Corp. of America · Sep 1990
ADD'L TRANSDUCER FOR USE W/EUB-165 ULTRASOUND
K901658 · Hitachi Medical Corp. of America · Sep 1990