Cleared Traditional

K892944 - INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515

K892944 is an FDA 510(k) clearance for INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515, 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 89-day FDA review.

K892944 · Interspec, Inc. · Cardiovascular device
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Jul 1989
Decision
89d
Days
Class 2
Risk

K892944 is an FDA 510(k) clearance for the INTERSPEC TRANSESOPHAGEAL PROBE MODEL 4515. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Interspec, Inc. (Conshohocken, US). The FDA issued a Cleared decision on July 19, 1989 after a review of 89 days - a notably fast clearance cycle.

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: 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 - K892944

510(k) Number K892944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 1989
Decision Date July 19, 1989
Days to Decision 89 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
36d faster than avg
Panel avg: 125d · This submission: 89d
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 K892944.
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