Cleared Traditional

K862913 - CARDIOSCAN WITH DOPPLER OPTION

K862913 is an FDA 510(k) clearance for CARDIOSCAN WITH DOPPLER OPTION, manufactured by Interspec, Inc.. The device is a Class 2 Cardiovascular device with product code JOP cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K862913 · Interspec, Inc. · Cardiovascular device
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Nov 1986
Decision
95d
Days
Class 2
Risk

K862913 is an FDA 510(k) clearance for the CARDIOSCAN WITH DOPPLER OPTION. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Interspec, Inc. (Conshohocken, US). The FDA issued a Cleared decision on November 4, 1986 after a review of 95 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2880 - 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.

View all Interspec, Inc. devices

FDA 510(k) Submission Details - K862913

510(k) Number K862913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1986
Decision Date November 04, 1986
Days to Decision 95 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
30d faster than avg
Panel avg: 125d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOP Device Classification - Class 2, Special Controls

Product Code JOP Transducer, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2880
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 - JOP Transducer, Ultrasonic

All 50
Devices cleared under the same product code (JOP) and FDA review panel - the closest regulatory comparables to K862913.
CONTINUOUS CARDIAC OUTPUT MONITORING SYSTEM
K870150 · Cardio Metrics, Inc. · Aug 1987
SSD-633 PHASED ARRAY SECTOR/LINEAR ULTRASOUND SYS.
K870916 · Ge Medical Systems Information Technologies · Jul 1987
3MHZ ANNULAR ARRAY
K864980 · Philips Ultrasound, Inc. · May 1987
ACUSON L558 TRANSDUCER
K861579 · Acuson Computed Sonography · Jul 1986
ACUSON S519 TRANSDUCER
K861596 · Acuson Computed Sonography · Jul 1986
MERIDIAN IMAGING SYSTEM
K861737 · Johnson & Johnson Professionals, Inc. · Jul 1986