Cleared Traditional

K843262 - TRANSESOPHAGEAL ECHOCARDIOGRAPHY ULTRASO

K843262 is the FDA 510(k) clearance for TRANSESOPHAGEAL ECHOCARDIOGRAPHY ULTRASO by Hewlett-Packard Co.. It is a Class 2 Cardiovascular device (product code JOP) cleared through the Traditional 510(k) pathway after a 3-day FDA review.

K843262 · Hewlett-Packard Co. · Cardiovascular device
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Aug 1984
Decision
3d
Days
Class 2
Risk

K843262 is an FDA 510(k) clearance for the TRANSESOPHAGEAL ECHOCARDIOGRAPHY ULTRASO. Classified as Transducer, Ultrasonic (product code JOP), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Walker, US). The FDA issued a Cleared decision on August 23, 1984 after a review of 3 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 Hewlett-Packard Co. devices

Submission Details

510(k) Number K843262 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1984
Decision Date August 23, 1984
Days to Decision 3 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
122d faster than avg
Panel avg: 125d · This submission: 3d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 28
Devices cleared under the same product code (JOP) and FDA review panel - the closest regulatory comparables to K843262.
ULTRASOUND 72X & ANNULAR ARRAY SCAN-
K843165 · Advanced Technology Laboratories, Inc. · Dec 1984
SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 8
K843129 · Advanced Technology Laboratories, Inc. · Dec 1984
SCANHEAD 2.25MHZ ADDED TO ULTRAMARK 4
K843130 · Advanced Technology Laboratories, Inc. · Dec 1984
USCI DOPPLER CATHETER SYSTEM
K810414 · C.R. Bard, Inc. · Aug 1981