Cleared Traditional

K842318 - YKI-770 ELECTRONIC SPHYGMOMAMETER

K842318 is an FDA 510(k) clearance for YKI-770 ELECTRONIC SPHYGMOMAMETER, manufactured by Yukosha Co., Inc.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K842318 · Yukosha Co., Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1985
Decision
247d
Days
Class 2
Risk

K842318 is an FDA 510(k) clearance for the YKI-770 ELECTRONIC SPHYGMOMAMETER. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Yukosha Co., Inc. (Walker, US). The FDA issued a Cleared decision on February 14, 1985 after a review of 247 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 Yukosha Co., Inc. devices

FDA 510(k) Submission Details - K842318

510(k) Number K842318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 1984
Decision Date February 14, 1985
Days to Decision 247 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
122d slower than avg
Panel avg: 125d · This submission: 247d
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 921
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K842318.
DINAMAP VITAL SIGNS MONITOR 1846 SX & 1846P SX
K844839 · Critikon Company, LLC · Apr 1985
CALCULATING CUFF INFLATOR TD312
K842067 · D. E. Hokanson, Inc. · Mar 1985
ACCUTORR CSM SYSTEM
K842538 · Datascope Corp. · Mar 1985
MUSE-DP
K840932 · Marquette Electronics, Inc. · Oct 1984
NON-INVASIVE BP MODULE 7000
K841336 · Marquette Electronics, Inc. · Oct 1984
AUTOMATED NON-INVASIVE PRESSURE MODULE
K840909 · Gould, Inc. · Jun 1984