Cleared Abbreviated

K062098 - SPECTRUM MONITOR

K062098 is the FDA 510(k) clearance for SPECTRUM MONITOR by Datascope Corp.. It is a Class 2 Cardiovascular device (product code MHX) cleared through the Abbreviated 510(k) pathway after a 196-day FDA review.

K062098 · Datascope Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
196d
Days
Class 2
Risk

K062098 is an FDA 510(k) clearance for the SPECTRUM MONITOR, MODEL 0998-00-1000-XXXXX. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Datascope Corp. (Mahwh, US). The FDA issued a Cleared decision on February 5, 2007 after a review of 196 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Datascope Corp. devices

Submission Details

510(k) Number K062098 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2006
Decision Date February 05, 2007
Days to Decision 196 days
Submission Type Abbreviated
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
71d slower than avg
Panel avg: 125d · This submission: 196d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 256
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K062098.
HYPERVISOR VI CENTRAL MONITORING SYSTEM
K062194 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Apr 2007
PHILIPS SURESIGNS VSV (VITAL SIGNS VIEWER)
K070588 · Philips Medical Systems · Mar 2007
INFINITY TELESMART TELEMETRY SYSTEM
K061379 · Draeger Medical Systems, Inc. · Feb 2007
MRI MONITOR WITH L-CANE05 AND L-CANE05A SOFTWARE AND MODULE OPTIONS N-PSNGV, N-PSNG, N-SNGV, N-SNG, N-PSN, N-SN
K062324 · Ge Healthcare · Dec 2006
M3290A INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE J.00 (FOR M3140, M3145, M3150, M3151, M3154, M3155, M3169, M3170)
K062271 · Philips Medical Systems · Nov 2006
INTELLIVUE PATIENT MONITORS, MODELS MP20, MP30, MP40, MP50, MP60, MP70, MP80 AND MP90
K063315 · Philips Medizin Systeme Boeblingen GmbH · Nov 2006