Cleared Traditional

K833170 - FLUSH DEVICE

K833170 is an FDA 510(k) clearance for FLUSH DEVICE, manufactured by Transamerica Delaval, Inc.. The device is a Class 2 Cardiovascular device with 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

FDA 510(k) Submission Details - K833170

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.

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 105
Devices cleared under the same product code (DRS) and FDA review panel - the closest regulatory comparables to K833170.
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K840023 · American Bentley · Jun 1984
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K840121 · Hewlett-Packard Co. · May 1984