Cleared Traditional

K950536 - PICIS CHART+

K950536 is an FDA 510(k) clearance for PICIS CHART+, manufactured by Picis. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K950536 · Picis · Cardiovascular device
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May 1995
Decision
99d
Days
Class 2
Risk

K950536 is an FDA 510(k) clearance for the PICIS CHART+. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Picis (Spain, ES). The FDA issued a Cleared decision on May 17, 1995 after a review of 99 days - within the typical 510(k) review window.

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 Picis devices

FDA 510(k) Submission Details - K950536

510(k) Number K950536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1995
Decision Date May 17, 1995
Days to Decision 99 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 125d · This submission: 99d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MHX Device Classification - Class 2, Special Controls

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 415
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K950536.
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PORTABLE PATIENT MONITOR
K945134 · Hewlett-Packard Co. · Oct 1994