Cleared Traditional

K841968 - DESERET DISPOSABLE PRESSURE TRANSDUCER

K841968 is an FDA 510(k) clearance for DESERET DISPOSABLE PRESSURE TRANSDUCER, manufactured by Parke-Davis Co.. The device is a Class 2 Cardiovascular device with product code DRS cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K841968 · Parke-Davis Co. · Cardiovascular device
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Aug 1984
Decision
83d
Days
Class 2
Risk

K841968 is an FDA 510(k) clearance for the DESERET DISPOSABLE PRESSURE TRANSDUCER. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Parke-Davis Co. (Mchenry, US). The FDA issued a Cleared decision on August 6, 1984 after a review of 83 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 Parke-Davis Co. devices

FDA 510(k) Submission Details - K841968

510(k) Number K841968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1984
Decision Date August 06, 1984
Days to Decision 83 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
42d faster than avg
Panel avg: 125d · This submission: 83d
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 K841968.
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