Cleared Traditional

K851486 - GOULD DISPOSABLE TRANSDUCER & ACCESSORI...

K851486 is the FDA 510(k) clearance for GOULD DISPOSABLE TRANSDUCER & ACCESSORI... by Gould, Inc.. It is a Class 2 Cardiovascular device (product code DRS) cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K851486 · Gould, Inc. · Cardiovascular device
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Oct 1985
Decision
185d
Days
Class 2
Risk

K851486 is an FDA 510(k) clearance for the GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Gould, Inc. (Oxnard, US). The FDA issued a Cleared decision on October 17, 1985 after a review of 185 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2850 - 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 Gould, Inc. devices

Submission Details

510(k) Number K851486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1985
Decision Date October 17, 1985
Days to Decision 185 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d slower than avg
Panel avg: 125d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRS Transducer, Blood-pressure, Extravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2850
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 - DRS Transducer, Blood-pressure, Extravascular

All 32
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K851486.
MINIFLOW DISPOSABLE PRESSURE TRANSDUCER 63-600F
K885296 · Baxter Healthcare Corp · Jan 1989
TRANTEC DISPOSABLE PRESSURE TRANS.53-600/F/F30
K872596 · American Edwards Laboratories · Sep 1987
DISPOSABLE FLUSH DEVICE
K860681 · Hewlett-Packard Co. · Jun 1986
APM DISPOS. BLOOD PRESSURE TRANSDUCER
K851888 · Honeywell, Inc. · Aug 1985
DISPOS. PRESSURE KIT 1295K SERIES
K843273 · Hewlett-Packard Co. · Jun 1985
PRESSURE TRANSDUCER DOME 1295C
K841613 · Hewlett-Packard Co. · Oct 1984