Cleared Traditional

K884420 - HOME BLOOD PRESSURE KIT, ANEROID

K884420 is an FDA 510(k) clearance for HOME BLOOD PRESSURE KIT, manufactured by Yamasu Co. , Ltd.. The device is a Class 3 Cardiovascular device with product code DXY cleared through the Traditional 510(k) pathway after a 309-day FDA review.

K884420 · Yamasu Co. , Ltd. · Cardiovascular device
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Aug 1989
Decision
309d
Days
Class 3
Risk

K884420 is an FDA 510(k) clearance for the HOME BLOOD PRESSURE KIT, ANEROID. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Yamasu Co. , Ltd. (Saitama Pref., JP). The FDA issued a Cleared decision on August 25, 1989 after a review of 309 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3610 - 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: High-complexity regulatory submission. High regulatory complexity profile. 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 Yamasu Co. , Ltd. devices

FDA 510(k) Submission Details - K884420

510(k) Number K884420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1988
Decision Date August 25, 1989
Days to Decision 309 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
184d slower than avg
Panel avg: 125d · This submission: 309d
Pathway characteristics
Predicate-based equivalence.

DXY Device Classification - Class 3, Premarket Approval

Product Code DXY Implantable Pacemaker Pulse-generator
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3610
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - DXY Implantable Pacemaker Pulse-generator

All 394
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K884420.
ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS
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K894185 · Telectronics Pacing Systems, Inc. · Aug 1989
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K885267 · Pacesetter Systems · Mar 1989