Cleared Traditional

K921627 - DIGITAL BLOOD PRESSURE MONITOR MODEL #UF-101

K921627 is an FDA 510(k) clearance for DIGITAL BLOOD PRESSURE MONITOR MODEL #U..., manufactured by Showa Engineering Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K921627 · Showa Engineering Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
211d
Days
Class 2
Risk

K921627 is an FDA 510(k) clearance for the DIGITAL BLOOD PRESSURE MONITOR MODEL #UF-101. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Showa Engineering Co., Ltd. (Miami, US). The FDA issued a Cleared decision on November 3, 1992 after a review of 211 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 Showa Engineering Co., Ltd. devices

FDA 510(k) Submission Details - K921627

510(k) Number K921627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1992
Decision Date November 03, 1992
Days to Decision 211 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 125d · This submission: 211d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

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 912
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K921627.
OMRON OSCILLOMETRIC DIGITAL BLOOD PRESSURE MONIT.
K930798 · Omron Healthcare, Inc. · May 1993
OMRON WRIST DIGITAL BLOOD PRESSURE MONITOR HEM-601
K920778 · Omron Healthcare, Inc. · Dec 1992
OMRON OSCILLOMETRIC DIGIT BLOOD PRES MONIT-HEM-706
K914823 · Omron Healthcare, Inc. · Dec 1992
NIBP 9225 COMBI
K912815 · S & W Medico Teknik · Oct 1992
BP PUMP
K921074 · Bio-Tek Instruments, Inc. · Oct 1992
NGM NIBP MODULE
K911645 · Datex Division Instrumentarium Corp. · Mar 1992