Cleared Traditional

K891180 - TRANSESOPHAGEAL ULTRASOUND ACCESSORIES KIT

K891180 is an FDA 510(k) clearance for TRANSESOPHAGEAL ULTRASOUND ACCESSORIES KIT, manufactured by Ingress Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DXP cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K891180 · Ingress Technologies, Inc. · Cardiovascular device
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Jun 1989
Decision
101d
Days
Class 2
Risk

K891180 is an FDA 510(k) clearance for the TRANSESOPHAGEAL ULTRASOUND ACCESSORIES KIT. Classified as Transducer, Vessel Occlusion (product code DXP), Class II - Special Controls.

Submitted by Ingress Technologies, Inc. (Phoenix, US). The FDA issued a Cleared decision on June 15, 1989 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2890 - 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 Ingress Technologies, Inc. devices

FDA 510(k) Submission Details - K891180

510(k) Number K891180 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1989
Decision Date June 15, 1989
Days to Decision 101 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 125d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXP Device Classification - Class 2, Special Controls

Product Code DXP Transducer, Vessel Occlusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2890
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.