Odam: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Odam” (first 1983, latest 1998), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 146 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 | 0 | — |
| 2013 | 0 | — |
| 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 |
|---|---|---|---|
| LDD | Dc-Defibrillator, Low-Energy, (Including Paddles) | 3 | 3 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 | 2 |
| DYC | Vectorcardiograph | 1 | 1 |
Review panels
- Cardiovascular (6)
Most recent Odam 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K972535 | MAGLIFE C | MHX | 1998-01-13 | 189 |
| K950264 | MAGLIFE | MHX | 1996-09-27 | 613 |
| K854175 | DEFIGARD 2000 | LDD | 1986-01-13 | 90 |
| K823934 | CARIEL F12 | DYC | 1983-12-16 | 352 |
| K823933 | MINIDEF (OR DEFIPORT | LDD | 1983-04-12 | 104 |
| K823931 | DEFIGARD M(OR DEFISCOPE M | LDD | 1983-04-12 | 104 |
Recalls
openFDA lists no recalls under a recalling firm named Odam.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Odam?
FDA lists 6 510(k) clearances under the applicant name “Odam” (first 1983, latest 1998), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Odam?
The median time from FDA receipt to decision across 510(k)s cleared under the name Odam is 146 days.
Which FDA product codes appear under Odam?
The most frequent FDA product codes under this applicant name are LDD (Dc-Defibrillator, Low-Energy, (Including Paddles), 3); MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), 2); DYC (Vectorcardiograph, 1).
Next steps
- See all 6 Odam clearances with predicates and recalls
- Run predicate analysis for product code LDD, Odam'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.