Cleared Special

K003004 - OSCAR 2

K003004 is the FDA 510(k) clearance for OSCAR 2 by Suntech Medical Instruments, Inc.. It is a Class 2 Cardiovascular device (product code DXN) cleared through the Special 510(k) pathway after a 30-day FDA review.

K003004 · Suntech Medical Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
30d
Days
Class 2
Risk

K003004 is an FDA 510(k) clearance for the OSCAR 2, MODEL 222. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Suntech Medical Instruments, Inc. (Hasbrouck Heights, US). The FDA issued a Cleared decision on October 25, 2000 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Suntech Medical Instruments, Inc. devices

Submission Details

510(k) Number K003004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2000
Decision Date October 25, 2000
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 520
Devices cleared under the same product code (DXN) and FDA review panel - the closest regulatory comparables to K003004.
DIGITAL BLOOD PRESSURE MONITORS, MODELS TM-2655, TM-2655P, & TM-2655VP
K010828 · A&D Engineering, Inc. · Mar 2001
BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520
K001543 · Welch Allyn, Inc. · Jan 2001
WELCH ALLYN SPOT CHECK DEVICE
K002530 · Welch Allyn, Inc. · Nov 2000
HL168B
K002882 · Health & Life Co., Ltd. · Oct 2000
DINAMAP PRO 1000 MONITOR, MODEL 1000
K002248 · Critikon Company, LLC · Sep 2000
HL168T
K002750 · Health & Life Co., Ltd. · Sep 2000