Cleared Traditional

K840228 - HEALTHCHECK AUTO INFLATE DIGITAL BP

K840228 is the FDA 510(k) clearance for HEALTHCHECK AUTO INFLATE DIGITAL BP by Timex Medical Products Corp.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K840228 · Timex Medical Products Corp. · Cardiovascular device
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May 1984
Decision
110d
Days
Class 2
Risk

K840228 is an FDA 510(k) clearance for the HEALTHCHECK AUTO INFLATE DIGITAL BP. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Timex Medical Products Corp. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1984 after a review of 110 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 Timex Medical Products Corp. devices

Submission Details

510(k) Number K840228 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1984
Decision Date May 09, 1984
Days to Decision 110 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 125d · This submission: 110d
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 544
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K840228.
AUTOMATED NON-INVASIVE PRESSURE MODULE
K840909 · Gould, Inc. · Jun 1984
DRAGER SPHYGMOMED
K840162 · Draeger Medical, Inc. · May 1984
TYCOS SELF CHECK BPM3 BLOOD PRESS MONI
K840469 · Sybron Corp. · May 1984
VERIFORM II
K833583 · American Medical Systems, Inc. · Jan 1984
ALPHA NON-INVASIVE BP CARDULE
K832764 · Spacelabs, Inc. · Jan 1984
NARCOTRACE 80
K830338 · Narco Scientific · Dec 1983