Cleared Special

K113054 - EQUIVITAL

K113054 is an FDA 510(k) clearance for EQUIVITAL, manufactured by Hidalgo Limited. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Special 510(k) pathway after a 127-day FDA review.

K113054 · Hidalgo Limited · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
127d
Days
Class 2
Risk

K113054 is an FDA 510(k) clearance for the EQUIVITAL. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Hidalgo Limited (Cambridge, GB). The FDA issued a Cleared decision on February 17, 2012 after a review of 127 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K113054

510(k) Number K113054 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2011
Decision Date February 17, 2012
Days to Decision 127 days
Submission Type Special
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
2d slower than avg
Panel avg: 125d · This submission: 127d
Pathway characteristics
Modification to existing cleared device.

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 425
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K113054.
PHYSIOLOGICAL MONITOR, PATIENT MONITOR
K113441 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Mar 2012
INTELLIVUE PATIENT MONITOR
K113657 · Philips Medizin Systeme Boblingen GmbH · Mar 2012
INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET
K113798 · Draeger Medical Systems, Inc. · Mar 2012
PATIENT MONITOR
K113653 · Edan Instruments, Inc. · Feb 2012
PATIENT MONITOR
K113623 · Edan Instruments, Inc. · Feb 2012
AVIVO MOBILE PATIENT MANAGEMENT
K113187 · Corventis, Inc. · Jan 2012
K113054 · EQUIVITAL
Download PDF FDA Summary Hidalgo Limited