Cleared Traditional

K972121 - ACUITY CENTRAL STATION

K972121 is an FDA 510(k) clearance for ACUITY CENTRAL STATION, manufactured by Protocol Systems, Inc.. The device is a Class 2 Cardiovascular device with product code MLD cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K972121 · Protocol Systems, Inc. · Cardiovascular device
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Nov 1997
Decision
155d
Days
Class 2
Risk

K972121 is an FDA 510(k) clearance for the ACUITY CENTRAL STATION. Classified as Monitor, St Segment With Alarm (product code MLD), Class II - Special Controls.

Submitted by Protocol Systems, Inc. (Beaverton, US). The FDA issued a Cleared decision on November 7, 1997 after a review of 155 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 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 Protocol Systems, Inc. devices

FDA 510(k) Submission Details - K972121

510(k) Number K972121 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1997
Decision Date November 07, 1997
Days to Decision 155 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
30d slower than avg
Panel avg: 125d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MLD Device Classification - Class 2, Special Controls

Product Code MLD Monitor, St Segment With Alarm
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 - MLD Monitor, St Segment With Alarm

All 12
Devices cleared under the same product code (MLD) and FDA review panel - the closest regulatory comparables to K972121.
DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES
K992323 · Datex-Ohmeda, Inc. · Nov 1999
ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500
K982104 · Medical Data Electronics · Nov 1998
SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WITH ST SEGMENT ANALYSIS
K974492 · Siemens Medical Solutions USA, Inc. · Feb 1998
AS/3 ESTPR MODULE
K953175 · Datex Division Instrumentarium Corp. · Feb 1997
EAGLE 3000/3100 PATIENT MONITOR
K960272 · Marquette Electronics, Inc. · Oct 1996
HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24
K960934 · Hewlett-Packard Co. · Jun 1996