Atom Medical Corporation: FDA filings under this applicant name
FDA lists 15 510(k) clearances under 3 spellings of the applicant name “Atom Medical Corporation” (first 2000, latest 2013), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 134 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 207 |
| 2013 | 1 | 154 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMZ | Incubator, Neonatal | 5 | 5 |
| FMT | Warmer, Infant Radiant | 4 | 4 |
| FPL | Incubator, Neonatal Transport | 2 | 2 |
| LBI | Unit, Neonatal Phototherapy | 2 | 2 |
| BTL | Ventilator, Emergency, Powered (Resuscitator) | 1 | 1 |
| BZR | Mixer, Breathing Gases, Anesthesia Inhalation | 1 | 1 |
Review panels
- General Hospital (13)
- Anesthesiology (2)
Most recent Atom Medical Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K123937 | ATOM TRANSCAPSULE V-707 | FPL | 2013-05-23 | 154 |
| K120937 | SUNFLOWER WARNER | FMT | 2012-07-06 | 100 |
| K111547 | BILI-THERAPY PAD TYPE | LBI | 2012-04-12 | 314 |
| K103317 | RESUSCITATION UNIT 105 | BZR | 2011-04-20 | 161 |
| K102542 | RESUSCI FLOW; RESUSCI FLOW 104 | BTL | 2011-04-06 | 215 |
| K103828 | BILI-THERAPY SPOT TYPE | LBI | 2011-03-29 | 91 |
| K102227 | INFA WARMER I | FMT | 2011-01-21 | 165 |
| K102226 | DUAL INCU I | FMZ | 2011-01-04 | 148 |
| K102279 | INCU I | FMZ | 2010-12-29 | 140 |
| K102710 | NEO-SERVO I | FMZ | 2010-12-22 | 93 |
5 earlier clearances. See the full list in Caduvo.
Recalls
5 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2012-05-01.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
FDA spellings included
FDA records this applicant under 3 spellings (case, punctuation and legal-suffix variants of one name); this page adds them up. Filings per spelling:
- Atom Medical Corporation (10)
- Atom Medical, Inc. (3)
- Atom Medical Corp (2)
Frequently asked questions
How many FDA 510(k) clearances are listed under Atom Medical Corporation?
FDA lists 15 510(k) clearances under 3 spellings of the applicant name “Atom Medical Corporation” (first 2000, latest 2013), across 6 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Atom Medical Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Atom Medical Corporation is 134 days.
Which FDA product codes appear under Atom Medical Corporation?
The most frequent FDA product codes under this applicant name are FMZ (Incubator, Neonatal, 5); FMT (Warmer, Infant Radiant, 4); FPL (Incubator, Neonatal Transport, 2).
Next steps
- See all 15 Atom Medical Corporation clearances with predicates and recalls
- Run predicate analysis for product code FMZ, Atom Medical Corporation's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.