Cleared Traditional

K012030 - PORTABLE INTENSIVE CARE UNIT

K012030 is an FDA 510(k) clearance for PORTABLE INTENSIVE CARE UNIT, manufactured by Medical Research Laboratories, Inc.. The device is a Class 3 Cardiovascular device with product code MKJ cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K012030 · Medical Research Laboratories, Inc. · Cardiovascular device
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Sep 2001
Decision
88d
Days
Class 3
Risk

K012030 is an FDA 510(k) clearance for the PORTABLE INTENSIVE CARE UNIT. Classified as Automated External Defibrillators (non-wearable) (product code MKJ), Class III - Premarket Approval.

Submitted by Medical Research Laboratories, Inc. (Buffalo Grove, US). The FDA issued a Cleared decision on September 24, 2001 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5310 - 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: High-complexity regulatory submission. High regulatory complexity profile. 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 Medical Research Laboratories, Inc. devices

FDA 510(k) Submission Details - K012030

510(k) Number K012030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 2001
Decision Date September 24, 2001
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

MKJ Device Classification - Class 3, Premarket Approval

Product Code MKJ Automated External Defibrillators (non-wearable)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.5310
Definition This Device Is A Non-wearable Prescription Use Only Aed. These Are Devices That Include Automated External Defibrillation. Automated External Defibrillators Use External Pad-type Electrodes To Sense, Detect, Classify And Treat (with An Electrical Shock) Ventricular Fibrillation. These Devices Are Intended To Be Used On Suspected Victims Of Sudden Cardiac Arrest. A Person In Cardiac Arrest Is Unresponsive And Is Not Breathing Normally. The Device Can Be Sold With Prescription Only.
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.

Regulatory Peers - MKJ Automated External Defibrillators (non-wearable)

All 118
Devices cleared under the same product code (MKJ) and FDA review panel - the closest regulatory comparables to K012030.
PORTABLE INTENSIVE CARE UNIT
K012766 · Medical Research Laboratories, Inc. · Jan 2002
HEARTSTREAMFR2 AED WITH M3848A AND M3849A, MODELS M3860A, M3861, M3840A, M3841A
K014157 · Philips Medical Systems · Jan 2002
HEARTSTREAM/HEARTSTART FR2 AED ECG CABLE, MODELS M3860A, M3861A, M3840A, M3841A
K013425 · Philips Medical Systems · Jan 2002
PORTABLE INSTENSIVE CARE UNIT
K010207 · Medical Research Laboratories, Inc. · Jun 2001
HEARTSTREAM XL DEFIBIBRILLATOR/MONITOR, MODEL M4735A, HEARTSTREAM XLT DEFIBRILLATOR/MONITOR.MODEL M2500B
K010634 · Agilent Technologies, Inc. · Jun 2001
HEARTSTREAM ATTENUATED DEFIBRILLATION PADS, MODEL M3870A
K003819 · Agilent Technologies, Inc. · May 2001