Cleared Traditional

K833170 - FLUSH DEVICE

K833170 is the FDA 510(k) clearance for FLUSH DEVICE by Transamerica Delaval, Inc.. It is a Class 2 Cardiovascular device (product code DRS) cleared through the Traditional 510(k) pathway after a 331-day FDA review.

K833170 · Transamerica Delaval, Inc. · Cardiovascular device
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Aug 1984
Decision
331d
Days
Class 2
Risk

K833170 is an FDA 510(k) clearance for the FLUSH DEVICE. Classified as Transducer, Blood-pressure, Extravascular (product code DRS), Class II - Special Controls.

Submitted by Transamerica Delaval, Inc. (Walker, US). The FDA issued a Cleared decision on August 12, 1984 after a review of 331 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Transamerica Delaval, Inc. devices

Submission Details

510(k) Number K833170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 1983
Decision Date August 12, 1984
Days to Decision 331 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
206d slower than avg
Panel avg: 125d · This submission: 331d
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 73
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K833170.
UTAH DISPOSABLE PRESSURE TRANSDUCER
K841788 · Utah Medical Products, Inc. · Mar 1985
PRESSURE MONITORING KIT
K842352 · Utah Medical Products, Inc. · Mar 1985
PRESSURE TRANSDUCER DOME 1295C
K841613 · Hewlett-Packard Co. · Oct 1984
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