Cleared Traditional

K822507 - DISPOSABLE TRANSDUCER & ACCESSORIES

K822507 is the FDA 510(k) clearance for DISPOSABLE TRANSDUCER & ACCESSORIES by Gould, Inc.. It is a Class 2 Cardiovascular device (product code DRS) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K822507 · Gould, Inc. · Cardiovascular device
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Sep 1982
Decision
26d
Days
Class 2
Risk

K822507 is an FDA 510(k) clearance for the DISPOSABLE TRANSDUCER & ACCESSORIES. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Gould, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1982 after a review of 26 days - a notably fast clearance 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: 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 Gould, Inc. devices

Submission Details

510(k) Number K822507 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1982
Decision Date September 14, 1982
Days to Decision 26 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
99d faster than avg
Panel avg: 125d · This submission: 26d
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 82
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K822507.
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