Cleared Traditional

K031153 - MONITOR, MODEL HSM-00200

Also marketed or referenced as:
PROBE, MODEL HSP-05065 JACKET, MODEL HSJ-05065

K031153 is an FDA 510(k) clearance for MONITOR, manufactured by Arrow Intl., Inc.. The device is a Class 2 Cardiovascular device with product code DPW cleared through the Traditional 510(k) pathway after a 228-day FDA review.

K031153 · Arrow Intl., Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2003
Decision
228d
Days
Class 2
Risk

K031153 is an FDA 510(k) clearance for the MONITOR, MODEL HSM-00200. Classified as Flowmeter, Blood, Cardiovascular (product code DPW), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Reading, US). The FDA issued a Cleared decision on November 25, 2003 after a review of 228 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2100 - 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 Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K031153

510(k) Number K031153 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2003
Decision Date November 25, 2003
Days to Decision 228 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
103d slower than avg
Panel avg: 125d · This submission: 228d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPW Device Classification - Class 2, Special Controls

Product Code DPW Flowmeter, Blood, Cardiovascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2100
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 - DPW Flowmeter, Blood, Cardiovascular

All 82
Devices cleared under the same product code (DPW) and FDA review panel - the closest regulatory comparables to K031153.
QUANTIX OR VESSEL STABILIZER DEVICE
K041180 · Cardiosonix, Ltd. · Jun 2004
ECHO SOUNDER EX-101EX 8 MHZ
K031931 · Koven Technology, Inc. · Feb 2004
ANGIOFLOW METER, ANGIOFLOW ANTEGRADE CATHETER, ANGIOFLOW RETROGRADE CATHETER, MODELS HVT100, ADT1001, ADT1002
K033424 · Transonic Systems, Inc. · Dec 2003
CAPIOX CARDIOTOMY RESERVOIR
K030505 · Terumo Cardiovascular Systems Corp. · May 2003
BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T
K010452 · Koven Technology, Inc. · Feb 2002
TISSUE SPECTROSCOPE
K992529 · Vital Medical , Ltd. · Nov 2000