510(k) Report

FDA applicant

Atom Medical Corporation

Bonita Springs, FL15 decisions2000–20135 recalls

FDA records 15 decisions for Atom Medical Corporation (Bonita Springs, FL) from 2000 to 2013: 15 510(k) clearances. Most are in product codes FMZ (Incubator, Neonatal) and FMT (Warmer, Infant Radiant). Its devices cite 23 predicates, 8 of them its own earlier devices. 5 recalls are linked to its devices.

FDA’s records also spell it “Atom Medical, Inc.”, “Atom Medical Corp”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general hospital panel, where it files most

How often FDA has decided Atom Medical Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2013

2010: 22011: 52012: 22013: 1
2007high 5 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2012

2011: 42012: 1
2007high 4 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Atom Medical Corporation by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FMZIncubator, Neonatal5decisions
  • FMTWarmer, Infant Radiant4decisions
  • LBIUnit, Neonatal Phototherapy2decisions
  • FPLIncubator, Neonatal Transport2decisions
  • BZRMixer, Breathing Gases, Anesthesia Inhalation1decision
  • BTLVentilator, Emergency, Powered (Resuscitator)1decision

Whose devices does it build on?

Its devices cite 23 predicates; 8 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 15 times; 8 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K002355Atom Infa Warmer V-505Atom Medical Corp · 20005cite it
  • K061856V-2200 Infant IncubatorAtom Medical, Inc. · 20063cite it
  • K021809V-2100G Advanced Infant IncubatorAtom Medical Corp · 20022cite it
  • K103828Bili-Therapy Spot TypeAtom Medical Corporation · 20112cite it
  • K060461V-505 Infa WarmerAtom Medical, Inc. · 20062cite it
  • K102710Neo-Servo IAtom Medical Corporation · 20101cites it

What has FDA decided for it lately?

  • K123937Atom Transcapsule V-707Atom Medical Corporation · 2013
  • K120937Sunflower WarnerAtom Medical Corporation · 2012
  • K111547Bili-Therapy Pad TypeAtom Medical Corporation · 2012
  • K103317Resuscitation Unit 105Atom Medical Corporation · 2011
  • K102542Resusci Flow; Resusci Flow 104Atom Medical Corporation · 2011
  • K103828Bili-Therapy Spot TypeAtom Medical Corporation · 2011
  • K102227Infa Warmer IAtom Medical Corporation · 2011
  • K102226Dual Incu IAtom Medical Corporation · 20115 recalls

All 10 as Atom Medical Corporation →All 3 as Atom Medical, Inc. →All 2 as Atom Medical Corp →

What has been recalled?

5 recalls linked to its devices; the latest:

  • K102226Dual Incu i, (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo…May 1, 2012Class II
  • K102226Infa Warmer i (Atom Infant Warmer Model 103) Atom Medical Corporation 3-18-15 Hongo…Aug 23, 2011
  • K102226Dual Incu i (Atom Infant Incubator Model 100) Atom Medical Corporation 3-18-15 Hongo…Aug 23, 2011
  • K102226Rabee Incu i (Atom Infant Incubator Model 102) Atom Medical Corporation 3-18-15 Hongo…Aug 23, 2011
  • K102226Incu i (Atom Infant Incubator Model 101) Atom Medical Corporation 3-18-15 Hongo…Aug 23, 2011