Cleared Traditional

K964153 - ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4000

K964153 is an FDA 510(k) clearance for ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRES..., manufactured by Rossmax International , Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 603-day FDA review.

K964153 · Rossmax International , Ltd. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 1998
Decision
603d
Days
Class 2
Risk

K964153 is an FDA 510(k) clearance for the ROSSMAX AUTOMATIC WRISTWATCH BLOOD PRESSURE MONITOR, MODEL RM-4000. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Rossmax International , Ltd. (Taipei, TW). The FDA issued a Cleared decision on June 11, 1998 after a review of 603 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Rossmax International , Ltd. devices

FDA 510(k) Submission Details - K964153

510(k) Number K964153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1996
Decision Date June 11, 1998
Days to Decision 603 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
478d slower than avg
Panel avg: 125d · This submission: 603d
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 858
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K964153.
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