Data / Medical devices / Japan / Atom Medical Corporation

Atom Medical Corporation: FDA-registered device maker in Sakura-ku, Saitama-shi, Japan, 13 510(k) clearances

Name: Atom Medical Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Atom Medical Corporation is registered with the FDA (registration 3005652389) in Sakura-ku, Saitama-shi, Japan. It lists 17 device types. The FDA files 13 510(k) clearances under its listings, the newest dated May 23, 2013. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005652389
FEI number: 3004846435
Address: 2-2-1, Dojo, Sakura-ku, Saitama-shi, Japan, 338-0835
Owner or operator: Atom Medical Corporation (9042398)
Roles: Exporter to the US, Manufacturer
First device listed: March 27, 2006
Registered through: 2026
Brand names listed: Atom Phototherapy Analyzer II

Devices it lists

Device	Product code	Class	Role	Source
Bassinet, Hospital	NZG	2	Manufacturer	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Manufacturer	accessdata.fda.gov
Cannula, Nasal, Oxygen	CAT	1	Manufacturer	accessdata.fda.gov
Colorimeter, Photometer, Spectrophotometer For Clinical Use	JJQ	1	Manufacturer	accessdata.fda.gov
Cover, Mattress (Medical Purposes)	FMW	1	Manufacturer	accessdata.fda.gov
Device, Medical Examination, Ac Powered	KZF	1	Manufacturer	accessdata.fda.gov
Incubator, Neonatal	FMZ	2	Manufacturer	accessdata.fda.gov
Incubator, Neonatal Transport	FPL	2	Manufacturer	accessdata.fda.gov
Mask, Oxygen	BYG	1	Manufacturer	accessdata.fda.gov
Mixer, Breathing Gases, Anesthesia Inhalation	BZR	2	Manufacturer	accessdata.fda.gov
Pad, Neonatal Eye	FOK	1	Exporter to the US	accessdata.fda.gov
Scale, Patient	FRW	1	Manufacturer	accessdata.fda.gov
Stethoscope, Manual	LDE	1	Manufacturer	accessdata.fda.gov
Timer, Apgar	LHB	1	Manufacturer	accessdata.fda.gov
Unit, Neonatal Phototherapy	LBI	2	Manufacturer	accessdata.fda.gov
Ventilator, Emergency, Powered (Resuscitator)	BTL	2	Manufacturer	accessdata.fda.gov
Warmer, Infant Radiant	FMT	2	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
May 23, 2013	K123937	ATOM TRANSCAPSULE V-707	FPL	Substantially Equivalent	Atom Medical Corporation	accessdata.fda.gov
July 6, 2012	K120937	SUNFLOWER WARNER	FMT	Substantially Equivalent	Atom Medical Corporation	accessdata.fda.gov
April 12, 2012	K111547	BILI-THERAPY PAD TYPE	LBI	Substantially Equivalent	Atom Medical Corporation	accessdata.fda.gov
April 20, 2011	K103317	RESUSCITATION UNIT 105	BZR	Substantially Equivalent	Atom Medical Corporation	accessdata.fda.gov
April 6, 2011	K102542	RESUSCI FLOW; RESUSCI FLOW 104	BTL	Substantially Equivalent	Atom Medical Corporation	accessdata.fda.gov
March 29, 2011	K103828	BILI-THERAPY SPOT TYPE	LBI	Substantially Equivalent	Atom Medical Corporation	accessdata.fda.gov
January 21, 2011	K102227	INFA WARMER I	FMT	Substantially Equivalent	Atom Medical Corporation	accessdata.fda.gov
January 4, 2011	K102226	DUAL INCU I	FMZ	Substantially Equivalent	Atom Medical Corporation	accessdata.fda.gov
December 29, 2010	K102279	INCU I	FMZ	Substantially Equivalent	Atom Medical Corporation	accessdata.fda.gov
December 22, 2010	K102710	NEO-SERVO I	FMZ	Substantially Equivalent	Atom Medical Corporation	accessdata.fda.gov
September 28, 2006	K061856	V-2200 INFANT INCUBATOR	FMZ	Substantially Equivalent	Atom Medical, Inc.	accessdata.fda.gov
August 29, 2006	K061071	V-808 ATOM TRANSCAPSULE	FPL	Substantially Equivalent	Atom Medical, Inc.	accessdata.fda.gov
July 18, 2002	K021809	V-2100G ADVANCED INFANT INCUBATOR	FMZ	Substantially Equivalent	Atom Medical Corp	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
May 1, 2012	61807	Class II	Terminated	Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan Usage: An incubator for infants.	There is a potential for the device's canopy to move unintentionally when using the incubator mode or radiant warmer mode.	accessdata.fda.gov
August 23, 2011	59767	Not yet classified	Terminated	Dual Incu i (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan Usage: A combination incubator and warmer for infants.	The caster with lock on the incubator or infant warmer may become loose or break.	accessdata.fda.gov

Compare with other makers

Updated May 23, 2013. 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.