Cleared Traditional

K841613 - PRESSURE TRANSDUCER DOME 1295C

K841613 is the FDA 510(k) clearance for PRESSURE TRANSDUCER DOME 1295C by Hewlett-Packard Co.. It is a Class 2 Cardiovascular device (product code DRS) cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K841613 · Hewlett-Packard Co. · Cardiovascular device
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Oct 1984
Decision
184d
Days
Class 2
Risk

K841613 is an FDA 510(k) clearance for the PRESSURE TRANSDUCER DOME 1295C. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Hewlett-Packard Co. (Andover, US). The FDA issued a Cleared decision on October 24, 1984 after a review of 184 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 Hewlett-Packard Co. devices

Submission Details

510(k) Number K841613 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1984
Decision Date October 24, 1984
Days to Decision 184 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
59d slower than avg
Panel avg: 125d · This submission: 184d
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 K841613.
MEDI-TRACE TRANSDUC PHYS PRESSURE MONITO
K843580 · Graphic Controls Corp. · May 1985
UTAH DISPOSABLE PRESSURE TRANSDUCER
K841788 · Utah Medical Products, Inc. · Mar 1985
PRESSURE MONITORING KIT
K842352 · Utah Medical Products, Inc. · Mar 1985
DESERET DISPOSABLE PRESSURE TRANSDUCER
K841968 · Parke-Davis Co. · Aug 1984
TRANTEC PHYSIOLOGICAL PRESSURE TRANSDUC
K840023 · American Bentley · Jun 1984
PHYSIOLOGICAL PRESSURE TRANSDUCER 1290C
K840121 · Hewlett-Packard Co. · May 1984