# Atom Medical Corporation

- Location (FDA's records): Bonita Springs, FL
- FDA decisions: 15 (2000–2013): 15 510(k) clearances
- Names in FDA's records: Atom Medical Corporation (10); Atom Medical, Inc. (3); Atom Medical Corp (2)
- Product codes: FMZ (5), FMT (4), LBI (2), FPL (2), BZR (1), BTL (1)
- Predicates its devices cite: 23 (8 its own); citations of its devices by later devices: 15 (8 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Air-Shields, Inc.: 3 (https://510kreport.com/company/air-shields)
- Masimo Corporation: 2 (https://510kreport.com/company/masimo)
- Respironics Inc., Sleep & Home Respiratory Group: 2 (https://510kreport.com/company/respironics-sleep-home-respiratory-group)
- Ohmeda Medical: 2 (https://510kreport.com/company/ohmeda-medical)
- Drager Medizintechnik GmbH: 1 (https://510kreport.com/company/drager-medizintechnik)
- Hill-Rom Air-Shields: 1 (https://510kreport.com/company/hill-rom-air-shields)
- GE Healthcare: 1 (https://510kreport.com/company/ge-healthcare)
- Biomedical Devices, Inc.: 1 (https://510kreport.com/company/biomedical-devices)

## Firms that cite its devices most
- Ohmeda Medical: 3 (https://510kreport.com/company/ohmeda-medical)
- Bio-Med USA, Inc.: 1 (https://510kreport.com/company/bio-med-usa)
- Neoforce Group, Inc.: 1 (https://510kreport.com/company/neoforce-group)
- International Biomedical: 1 (https://510kreport.com/company/international-biomedical)
- Bistos Co., Ltd.: 1 (https://510kreport.com/company/bistos)

## Its most-cited devices
- K002355: Atom Infa Warmer V-505 (2000), cited by 5
- K061856: V-2200 Infant Incubator (2006), cited by 3
- K021809: V-2100G Advanced Infant Incubator (2002), cited by 2
- K103828: Bili-Therapy Spot Type (2011), cited by 2
- K060461: V-505 Infa Warmer (2006), cited by 2
- K102710: Neo-Servo I (2010), cited by 1

## Recent decisions
- K123937: Atom Transcapsule  V-707 (May 23, 2013)
- K120937: Sunflower Warner (Jul 6, 2012)
- K111547: Bili-Therapy Pad Type (Apr 12, 2012)
- K103317: Resuscitation Unit 105 (Apr 20, 2011)
- K102542: Resusci Flow; Resusci Flow 104 (Apr 6, 2011)
- K103828: Bili-Therapy Spot Type (Mar 29, 2011)
- K102227: Infa Warmer I (Jan 21, 2011)
- K102226: Dual Incu I (Jan 4, 2011)

Source page: https://510kreport.com/company/atom-medical