Cleared Traditional

K030230 - AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR)

K030230 is an FDA 510(k) clearance for AVITA BPM1 SERIES (WRIST TYPE) BLOOD PR..., manufactured by Avita Corporation. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K030230 · Avita Corporation · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2003
Decision
121d
Days
Class 2
Risk

K030230 is an FDA 510(k) clearance for the AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR). Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Avita Corporation (Flagstaff, US). The FDA issued a Cleared decision on May 23, 2003 after a review of 121 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K030230

510(k) Number K030230 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 2003
Decision Date May 23, 2003
Days to Decision 121 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
4d faster than avg
Panel avg: 125d · This submission: 121d
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 1225
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K030230.
HL888RA
K031835 · Health & Life Co., Ltd. · Jul 2003
GENTEEL WRIST DIGITAL BLOOD PRESSURE MONITOR, MODEL BP-100
K022926 · Genteel Technology Co., Ltd. · Jun 2003
AMBULATORY BLOOD PRESSURE (ABP) 92506 REPORT MANAGEMENT SYSTEM (RMS), MODEL 92506
K031479 · Datex-Ohmeda, Inc. · Jun 2003
PORTAPRES AMBULATORY CONTINUOUS NON INVASIVE BLOOD PRESSURE MONITOR,MODEL-2
K023338 · Fms, Finapres Medical Systems BV · May 2003
MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODELS HPL-100 AND HPL-100A
K030561 · Mytech Technology Co., Ltd. · May 2003
CARECOMPANION PATIENT STATION/CARECOMPANION PATIENT STATION
K023286 · Neptec Design Group, Ltd. · May 2003
K030230 · AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR)
Download PDF FDA Summary Avita Corporation