Cleared Traditional

K001244 - BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D

K001244 is an FDA 510(k) clearance for BLOOD PRESSURE METER, manufactured by Citizen Watch Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K001244 · Citizen Watch Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2000
Decision
161d
Days
Class 2
Risk

K001244 is an FDA 510(k) clearance for the BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Citizen Watch Co., Ltd. (Washington, US). The FDA issued a Cleared decision on September 26, 2000 after a review of 161 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 Citizen Watch Co., Ltd. devices

FDA 510(k) Submission Details - K001244

510(k) Number K001244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2000
Decision Date September 26, 2000
Days to Decision 161 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
36d slower than avg
Panel avg: 125d · This submission: 161d
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 846
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K001244.
MODEL WS-500 DIGITAL WRIST BLOOD PRESSURE MONITOR
K003444 · Nihon Seimitsu Sokki Co., Ltd. · Nov 2000
WELCH ALLYN SPOT CHECK DEVICE
K002530 · Welch Allyn, Inc. · Nov 2000
HL168B
K002882 · Health & Life Co., Ltd. · Oct 2000
ZOLL M SERIES NIBP OPTION, MODEL MSERIES NIBP OPTION
K002029 · Zoll Medical Corp · Sep 2000
DINAMAP PRO 1000 MONITOR, MODEL 1000
K002248 · Critikon Company, LLC · Sep 2000
HL168T
K002750 · Health & Life Co., Ltd. · Sep 2000