Atlas FDA

PHILIPS M5066A AND M5068A

FDA 510(k) clearance K020715 · decided 2002-11-08

Clearance details

K-number
K020715
Device name
PHILIPS M5066A AND M5068A
Applicant
Philips Medical Systems
Decision
Substantially Equivalent - Subject to Tracking Reg.
Date received
2002-03-05
Decision date
2002-11-08
Days to decision
248 days
Clearance type
Abbreviated
Product code
MKJ
Device class
3
Regulation number
870.5310
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Seattle, WA, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

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LIFEPAK 15 monitor/defibrillator (K142430)Physio-Control, Inc.2014-12-19
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ZOLL X Series (K142915)ZOLL Medical Corporation2014-12-03
Skintact, various other tradenames (K142803)Leonhard Lang GmbH2014-12-02
ZP9141, ZP9146Y, ZP9146W NON-RECHARGEABLE BATTERY (K141231)Zeller Power Products (Battery Beast, LLC)2014-11-25
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Recalls involving this device

RecordFirmDate
Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product recall (Z-1232-2014)Philips Medical Systems North America Inc.2014-03-19
Philips and Laerdal brands of HeartStart HS1 Defibrillator Family Model number M5066A, M50 recall (Z-0643-2013)Philips Medical Systems North America Co. Phillips2013-01-04
Automated External Defibrillator(AED) of brand name "Philips HeartStart HS1 OnSite" (Model recall (Z-1916-2010)Philips Medical Systems2010-06-28
Automated External Defibrillator (AED) of brand name "Philips HeartStart HS1 Home" (Model recall (Z-1917-2010)Philips Medical Systems2010-06-28
Philips Heartstart (HS1) Onsite Automated External Defibrillator (AED) Catalog number M506 recall (Z-1194-2010)Philips Medical Systems2010-03-23
Heartstart (HS1) Laerdal brand onsite Automated External Defibrillator, Model M5067A recall (Z-1195-2010)Philips Medical Systems2010-03-23
Philips defibrillator, model M5066A. Sold in the US by Philips as an OTC under the brand n recall (Z-1779-2008)Philips Medical Systems2008-07-09
Laerdal "HeartStart Defibrillator", model M5067A, under Laerdal brand for Laerdal Medical recall (Z-1780-2008)Philips Medical Systems2008-07-09

PMA approvals by this applicant

RecordFirmDate
HeartStart FRx Defibrillator and HeartStart SMART Pads II (P180028/S017)Philips Medical Systems2025-09-05
HeartStart FRx Defibrillator (861304) (P180028/S016)Philips Medical Systems2025-06-09
HeartStart FRx Defibrillator (P180028/S015)Philips Medical Systems2025-05-09
HeartStart FRx Defibrillator (861304) (P180028/S014)Philips Medical Systems2024-02-21
HeartStart FRx Defibrillator (P180028/S013)Philips Medical Systems2023-04-03
HeartStart FRx Defibrillator (P180028/S012)Philips Medical Systems2022-03-20
HeartStart FRx Defibrillator (861304) (P180028/S011)Philips Medical Systems2021-11-15
HeartStart FRx Defibrillator (861304) (P180028/S010)Philips Medical Systems2021-09-24