Cleared Traditional

E-20 RAPID CUFF INFLATOR (K905367) - FDA 510(k) Clearance

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

K905367 · D. E. Hokanson, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1991
Decision
99d
Days
Class 2
Risk

K905367 is an FDA 510(k) clearance for the E-20 RAPID CUFF INFLATOR. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by D. E. Hokanson, Inc. (Bellevue, US). The FDA issued a Cleared decision on March 6, 1991 after a review of 99 days - within the typical 510(k) review window.

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 K905367 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1990
Decision Date March 06, 1991
Days to Decision 99 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 125d · This submission: 99d
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 244
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K905367.
Fully Automatic Electronic Blood Pressure Monitor
K162668 · Andon Health Co, Ltd. · Feb 2017
Fully Automatic Electronic Blood Pressure Monitor
K162915 · Andon Health Co, Ltd. · Feb 2017
iHealth Wireless Blood Pressure Monitor
K162144 · Andon Health Co, Ltd. · Feb 2017
HP MODEL M1008B, NONINVASIVE BLOOD PRESSURE MODULE
K903771 · Hewlett-Packard Co. · Feb 1991
AP-851PA NIBP MODULE
K894693 · Nihon Kohden America, Inc. · Oct 1989
POCKET MANOMETER
K880599 · Abbott Laboratories · Oct 1988