Cleared Traditional

K851486 - GOULD DISPOSABLE TRANSDUCER & ACCESSORIES-DTX

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

K851486 · Gould, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K851486

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
Combination Product No
PCCP Authorized No
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.

DRS Device Classification - Class 2, Special Controls

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 91
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K851486.
DISPOSABLE FLUSH DEVICE
K860681 · Hewlett-Packard Co. · Jun 1986
MODEL:TA-ROSE RESONANT OVERSHOOT ELIMINATOR
K855145 · Gould, Inc. · Feb 1986
CARDIMAX FX-406U
K854505 · Brentwood Instruments, Inc. · Feb 1986
BENTLEY-TRANTEC DISPOS. DOMES D-260-
K841811 · American Bentley · Sep 1985
APM DISPOS. BLOOD PRESSURE TRANSDUCER
K851888 · Honeywell, Inc. · Aug 1985
DISPOS. PRESSURE KIT 1295K SERIES
K843273 · Hewlett-Packard Co. · Jun 1985