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Philips North America LLC: FDA-registered device maker in Woodinville, WA, United States, 2 510(k) clearances and 3 PMA approvals

Name: Philips North America LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Philips North America LLC is registered with the FDA (registration 3012607778) in Woodinville, WA, United States. It lists 4 device types. The FDA files 2 510(k) clearances and 3 PMA approvals under its listings, the newest dated May 11, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3012607778
Address: 15100 Woodinville-Redmond Road NE Bldg A, Suite 300, Woodinville, WA, United States, 98072
Owner or operator: Philips Medical Systems International BV (1217116)
Roles: Manufacturer, Specification developer
First device listed: August 24, 1999
Registered through: 2026
Brand names listed: 05-10000 - Heartstream Pads to QUIK-COMBO Adapter [FR2], 05-10100 - Heartstream Pads to Zoll Adapter, 68-PCHAT, Fast Respond Kit, 861304 HeartStart FRx Defibrillator, 989803139261 SMART Pads II, 989803139301 Aviation FRx Battery, 989803139311 Infant/Child Key, 989803149981 and 989803149991 SMART Pads III and more

Devices it lists

Device	Product code	Class	Role	Source
Automated External Defibrillators (Non-Wearable)	MKJ	3	Manufacturer, Specification developer	accessdata.fda.gov
Cable, Electrode	IKD	2	Specification developer	accessdata.fda.gov
Mask, Oxygen, Non-Rebreathing	KGB	1	Specification developer	accessdata.fda.gov
Over-The-Counter Automated External Defibrillator	NSA	3	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 17, 1998	K984286	HEARTSTREAM ELECTRODE ADAPTER	MKJ	Substantially Equivalent	Hewlett-Packard Co.	accessdata.fda.gov
September 25, 1997	K972418	HEARTSTRAMELECTRODE ADAPTER(EA-XX SERIES)/HEARTSTRAM DEFIBRILLATION PADS WITH PREATTACHED ELECTRODE ADAPTER(DP-EAXX)	MKJ	Substantially Equivalent	Heartstream, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
May 11, 2020	P180028	HeartStart FRx Defibrillator	MKJ	19	May 21, 2026	accessdata.fda.gov
May 11, 2020	P160028	Philips HeartStart FR3 Defibrillator	MKJ	7	May 21, 2026	accessdata.fda.gov
June 6, 2019	P160029	HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A)	NSA	26	February 2, 2026	accessdata.fda.gov

Compare with other makers

Updated May 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.