Cleared Traditional

CALCULATING CUFF INFLATOR TD312 (K842067) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K842067 · D. E. Hokanson, Inc. · Cardiovascular device
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Mar 1985
Decision
282d
Days
Class 2
Risk

K842067 is an FDA 510(k) clearance for the CALCULATING CUFF INFLATOR TD312. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by D. E. Hokanson, Inc. (Issaquah, US). The FDA issued a Cleared decision on March 1, 1985 after a review of 282 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - 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 D. E. Hokanson, Inc. devices

Submission Details

510(k) Number K842067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1984
Decision Date March 01, 1985
Days to Decision 282 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 125d · This submission: 282d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
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 - DXN System, Measurement, Blood-pressure, Non-invasive

All 246
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K842067.
NBP 488, TPR 488
K861856 · Siemens Medical Solutions USA, Inc. · Dec 1986
MPV-7201 NON-INVASIVE BLOOD PRESSURE MONITOR
K854370 · Nihon Kohden America, Inc. · Apr 1986
MODEL 9300 TREND ANALYZING BIO-MONITOR SYS
K844252 · Medtronic Vascular · Jun 1985
HYPER CHEC, SPHYGMOMANOMETER ELECTRONIC
K791054 · C.R. Bard, Inc. · Jul 1979
QUICK-CHECK
K790277 · United States Surgical, A Division of Tyco Healthc · Mar 1979
PRESSURE INFUSION CUFF
K781556 · Abbott Laboratories · Oct 1978