Atom Medical Corporation
Sakura-ku, Saitama-shi, JP
ATOM MEDICAL CORPORATION appears in FDA device records in Sakura-ku, Saitama-shi, JP. FDA records list 15 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 5 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 15 510(k) clearances for Atom Medical Corporation between 2000 and 2013. The busiest year on record is 2011, with 5. The most recent is 2013, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2000 | 1 |
| 2002 | 1 |
| 2006 | 3 |
| 2010 | 2 |
| 2011 | 5 |
| 2012 | 2 |
| 2013 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K123937 | ATOM TRANSCAPSULE V-707 | FPL | Substantially Equivalent | |
| K120937 | SUNFLOWER WARNER | FMT | Substantially Equivalent | |
| K111547 | BILI-THERAPY PAD TYPE | LBI | Substantially Equivalent | |
| K103317 | RESUSCITATION UNIT 105 | BZR | Substantially Equivalent | |
| K102542 | RESUSCI FLOW; RESUSCI FLOW 104 | BTL | Substantially Equivalent | |
| K103828 | BILI-THERAPY SPOT TYPE | LBI | Substantially Equivalent | |
| K102227 | INFA WARMER I | FMT | Substantially Equivalent | |
| K102226 | DUAL INCU I | FMZ | Substantially Equivalent | |
| K102279 | INCU I | FMZ | Substantially Equivalent | |
| K102710 | NEO-SERVO I | FMZ | Substantially Equivalent | |
| K061856 | V-2200 INFANT INCUBATOR | FMZ | Substantially Equivalent | |
| K061071 | V-808 ATOM TRANSCAPSULE | FPL | Substantially Equivalent | |
| K060461 | V-505 INFA WARMER | FMT | Substantially Equivalent | |
| K021809 | V-2100G ADVANCED INFANT INCUBATOR | FMZ | Substantially Equivalent | |
| K002355 | ATOM INFA WARMER V-505 | FMT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005652389 | 3004846435 | ATOM MEDICAL CORPORATION | 2-2-1, Dojo,, Sakura-ku, Saitama-shi 338-0835 JP | 2026 | and 7 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NZGBassinet, Hospital
- KMEBedding, Disposable, Medical
- CATCannula, Nasal, Oxygen
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- FMWCover, Mattress (Medical Purposes)
- KZFDevice, Medical Examination, Ac Powered
- FMZIncubator, Neonatal
- FPLIncubator, Neonatal Transport
- BYGMask, Oxygen
- BZRMixer, Breathing Gases, Anesthesia Inhalation
- FOKPad, Neonatal Eye
- FRWScale, Patient
- LDEStethoscope, Manual
- LHBTimer, Apgar
- LBIUnit, Neonatal Phototherapy
- BTLVentilator, Emergency, Powered (Resuscitator)
- FMTWarmer, Infant Radiant
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1945-2012 | Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 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. | Class II | Terminated | |
| Z-0340-2012 | Infa Warmer i (Atom Infant Warmer Model 103) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: A warmer for infants. | The caster with lock on the radiant-warming open type incubator may become loose or break. | Terminated | ||
| Z-0339-2012 | Rabee Incu i (Atom Infant Incubator Model 102) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants. | The caster with lock on the incubator may become loose or break. | Terminated | ||
| Z-0338-2012 | Incu i (Atom Infant Incubator Model 101) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: An incubator for infants. | The caster with lock on the incubator may become loose or break. | Terminated | ||
| Z-0337-2012 | Dual Incu i (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo, Bunkyo-Ku, Tokyo, Japan 113-0033 Usage: A combination incubator and warmer for infants. | The caster with lock on the incubator or infant warmer may become loose or break. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain