Nats Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Nats Corp.” (first 1999, latest 2004), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 86 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 |
|---|---|---|---|
| BSB | Warmer, Blood, Non-Electromagnetic Radiation | 1 | 1 |
| DZE | Implant, Endosseous, Root-Form | 1 | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
| ILJ | Bath, Hydro-Massage | 1 | 1 |
| ITI | Wheelchair, Powered | 1 | 1 |
Review panels
- Dental (2)
- Physical Medicine (2)
- Hematology (1)
Most recent Nats Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K040143 | MONORAIL | DZE | 2004-09-13 | 235 |
| K033142 | POWERED WHEELCHAIR | ITI | 2004-05-19 | 232 |
| K020060 | ASTOFLO | BSB | 2002-03-05 | 56 |
| K011820 | DENTORIUM CONVERTIBLE ACRYLIC | EBI | 2001-09-05 | 86 |
| K991184 | HYDROTONE-THERMAL CAPSULE SYSTEM | ILJ | 1999-06-23 | 76 |
Recalls
openFDA lists no recalls under a recalling firm named Nats Corp..
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 Nats Corp.?
FDA lists 5 510(k) clearances under the applicant name “Nats Corp.” (first 1999, latest 2004), across 5 product codes in 3 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 Nats Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nats Corp. is 86 days.
Which FDA product codes appear under Nats Corp.?
The most frequent FDA product codes under this applicant name are BSB (Warmer, Blood, Non-Electromagnetic Radiation, 1); DZE (Implant, Endosseous, Root-Form, 1); EBI (Resin, Denture, Relining, Repairing, Rebasing, 1).
Next steps
- See all 5 Nats Corp. clearances with predicates and recalls
- Run predicate analysis for product code BSB, Nats Corp.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.