Ergo Intl., Ent., Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Ergo Intl., Ent., Inc.” (first 1988, latest 1989), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 45 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 |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | 4 | 4 |
| KGO | Surgeon'S Gloves | 1 | 1 |
Review panels
- General Hospital (5)
Most recent Ergo Intl., Ent., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K892166 | NON-STERILE PATIENT EXAM GLOVES (LATEX) | LYY | 1989-07-14 | 100 |
| K892026 | PROLAX PATIENT EXAMINATION GLOVES (LATEX) | LYY | 1989-05-25 | 56 |
| K892101 | PATIENT EXAM GLOVES (MFG. SHUN TAHI RUBBER GLOVES) | LYY | 1989-05-08 | 35 |
| K892100 | PATIENT EXAM GLOVES (MFG. SHUN JUN TRADING CO.) | LYY | 1989-05-08 | 35 |
| K884030 | ERGO II, SURGICAL LATEX GLOVES | KGO | 1988-11-07 | 45 |
Recalls
openFDA lists no recalls under a recalling firm named Ergo Intl., Ent., Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Ergo Instruments, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ergo Intl., Ent., Inc.?
FDA lists 5 510(k) clearances under the applicant name “Ergo Intl., Ent., Inc.” (first 1988, latest 1989), across 2 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 Ergo Intl., Ent., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ergo Intl., Ent., Inc. is 45 days.
Which FDA product codes appear under Ergo Intl., Ent., Inc.?
The most frequent FDA product codes under this applicant name are LYY (Latex Patient Examination Glove, 4); KGO (Surgeon'S Gloves, 1).
Next steps
- See all 5 Ergo Intl., Ent., Inc. clearances with predicates and recalls
- Run predicate analysis for product code LYY, Ergo Intl., Ent., Inc.'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.