Cleared Special

K010214 - FIRSTSAVE BIPHASIC MODEL #9200 AND 9210

K010214 is an FDA 510(k) clearance for FIRSTSAVE BIPHASIC MODEL #9200 AND 9210, manufactured by Survivalink Corp.. The device is a Class 3 Cardiovascular device with product code MKJ cleared through the Special 510(k) pathway after a 30-day FDA review.

K010214 · Survivalink Corp. · Cardiovascular device
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Feb 2001
Decision
30d
Days
Class 3
Risk

K010214 is an FDA 510(k) clearance for the FIRSTSAVE BIPHASIC MODEL #9200 AND 9210. Classified as Automated External Defibrillators (non-wearable) (product code MKJ), Class III - Premarket Approval.

Submitted by Survivalink Corp. (Minnetonka, US). The FDA issued a Cleared decision on February 22, 2001 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

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 Survivalink Corp. devices

FDA 510(k) Submission Details - K010214

510(k) Number K010214 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2001
Decision Date February 22, 2001
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 143
Devices cleared under the same product code (MKJ) and FDA review panel - the closest regulatory comparables to K010214.
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
ZOLL M SERIES
K010257 · Zoll Medical Corp · Feb 2001
PAD PRO PEDIATRIC ELECTRODE, MODEL PAD PRO 2602
K002280 · Medical Devices, Inc. · Feb 2001
HEARTSTREAM FR2 AED, MODEL M3860A,M3861A
K003565 · Agilent Technologies, Inc. · Dec 2000
K-DEFIB/PACE MULTIFUCTION PEDIATRIC ELECTRODE, MODEL KDP-70A
K003228 · Katecho, Inc. · Dec 2000