Infab Corp.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Infab Corp.” (first 1989, latest 1990), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 36 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 |
|---|---|---|---|
| KPY | Shield, Protective, Personnel | 2 | 2 |
| EAM | Screen, Intensifying, Radiographic | 1 | 1 |
| IWP | Radiographic Protective Glove | 1 | 1 |
| IXA | Cassette, Radiographic Film | 1 | 1 |
| IXJ | Grid, Radiographic | 1 | 1 |
Review panels
- Radiology (6)
Most recent Infab Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K900972 | RADIATION PROTECTION GLOVES | IWP | 1990-05-01 | 60 |
| K900970 | RADIATION PROTECTION GLASSES | KPY | 1990-05-01 | 60 |
| K901014 | RADIOGRAPHIC INTENSIFYING SCREEN | EAM | 1990-04-02 | 28 |
| K901013 | RADIOGRAPHIC FILM CASSETTE | IXA | 1990-03-28 | 23 |
| K901012 | RADIOGRAPHIC GRID | IXJ | 1990-03-28 | 23 |
| K896289 | RADIATION PROTECTION APRON | KPY | 1989-12-14 | 44 |
Recalls
openFDA lists no recalls under a recalling firm named Infab 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 Infab Corp.?
FDA lists 6 510(k) clearances under the applicant name “Infab Corp.” (first 1989, latest 1990), across 5 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 Infab Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Infab Corp. is 36 days.
Which FDA product codes appear under Infab Corp.?
The most frequent FDA product codes under this applicant name are KPY (Shield, Protective, Personnel, 2); EAM (Screen, Intensifying, Radiographic, 1); IWP (Radiographic Protective Glove, 1).
Next steps
- See all 6 Infab Corp. clearances with predicates and recalls
- Run predicate analysis for product code KPY, Infab 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 (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.