Cleared Traditional

K854797 - TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER

K854797 is the FDA 510(k) clearance for TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER by Takeda Medical, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K854797 · Takeda Medical, Inc. · Cardiovascular device
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May 1986
Decision
158d
Days
Class 2
Risk

K854797 is an FDA 510(k) clearance for the TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER, UA-731. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Takeda Medical, Inc. (Irvine, US). The FDA issued a Cleared decision on May 9, 1986 after a review of 158 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 Takeda Medical, Inc. devices

Submission Details

510(k) Number K854797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 1985
Decision Date May 09, 1986
Days to Decision 158 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 125d · This submission: 158d
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 537
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K854797.
HORIZON 2000 NON-INVASIVE BLOOD PRESSURE CAP.
K854942 · Mennen Medical, Inc. · Jun 1986
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K854434 · Critikon Company, LLC · May 1986
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K860196 · Cas Medical Systems, Inc. · May 1986
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K854370 · Nihon Kohden America, Inc. · Apr 1986
WELCH ALLYN MODEL 40000 SPHYG W/ 40030-35 BLAD & C
K852574 · Welch Allyn, Inc. · Mar 1986
MODEL 9300 TREND ANALYZING BIO-MONITOR SYS
K844252 · Medtronic Vascular · Jun 1985