Eci Medical Technologies, Inc.: FDA clearances and approvals
Eci Medical Technologies, Inc. has 9 FDA 510(k) clearances (first 1995, latest 2002), across 2 product codes in 1 review panel. Median 510(k) review time: 73 days.
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 |
|---|---|---|---|
| KGO | Surgeon'S Gloves | 6 | 6 |
| LZA | Polymer Patient Examination Glove | 3 | 3 |
Review panels
- General Hospital (9)
Most recent Eci Medical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K021598 | ELASTYLITE SYNTHETIC POWDERED SURGICAL GLOVE | KGO | 2002-06-10 | 26 |
| K020918 | ELASTYFREE SYNTHETIC POWDER-FREE SURGICAL GLOVE | KGO | 2002-04-19 | 29 |
| K984337 | ELASTYLON POWDER-FREE SURGICAL GLOVE | KGO | 1999-04-09 | 127 |
| K971471 | ELASTYREN POWDER-FREE SURGICAL GLOVE | KGO | 1998-02-09 | 292 |
| K970015 | ELASTYREN POWDER-FREE PATIENT EXAMINATION GLOVES | LZA | 1997-06-24 | 173 |
| K954535 | ELASTYREN HYPOALLERGENIC SURGICAL GLOVES | KGO | 1995-12-11 | 73 |
| K954533 | ELASTYREN HYPOALLERGENIC PATIENT EXAMINATION GLOVES | LZA | 1995-12-11 | 73 |
| K946291 | ELASTYREN(R) PATIENT EXAMINATION GLOVES | LZA | 1995-02-14 | 49 |
| K945833 | ELASTYREN(R) SURGICAL GLOVES | KGO | 1995-01-17 | 49 |
Recalls
openFDA lists no recalls under a recalling firm named Eci Medical Technologies, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Eci Medical Technologies, Inc. have?
Eci Medical Technologies, Inc. has 9 FDA 510(k) clearances (first 1995, latest 2002), across 2 product codes in 1 review panel.
How long does FDA take to clear Eci Medical Technologies, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Eci Medical Technologies, Inc.'s cleared 510(k)s is 73 days.
What devices does Eci Medical Technologies, Inc. make?
Its most frequent FDA product codes are KGO (Surgeon'S Gloves, 6); LZA (Polymer Patient Examination Glove, 3).
Has Eci Medical Technologies, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Eci Medical Technologies, Inc. Related entities may recall under other names.
Next steps
- See all 9 Eci Medical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KGO, Eci Medical Technologies, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.