Aspen Labs: FDA clearances and approvals
Aspen Labs has 6 FDA 510(k) clearances (first 1991, latest 1997), across 4 product codes in 2 review panels. Median 510(k) review time: 230 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 |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 2 | 2 |
| HGI | Electrocautery, Gynecologic (And Accessories) | 2 | 2 |
| DWG | Electrosurgical Device | 1 | 1 |
| HFG | Coagulator, Laparoscopic, Unipolar (And Accessories) | 1 | 1 |
Review panels
Most recent Aspen Labs 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K970493 | HYFRECATOR 2000 | GEI | 1997-04-30 | 79 |
| K925333 | SINGLE USE TUNGSTEN WIRE LEE LOOP ELECTRODE | HGI | 1994-09-27 | 706 |
| K931215 | HAND-TROL S | DWG | 1994-03-28 | 383 |
| K912046 | SINGLE USE LEE ELECTRODE | HGI | 1992-03-05 | 302 |
| K905654 | ELECTROSURGICAL UNIT WITH ACCESSORIES | GEI | 1991-03-18 | 90 |
| K904240 | SINGLE USE LAPARSCOPIC ELECTRODE | HFG | 1991-02-19 | 159 |
Recalls
openFDA lists no recalls under a recalling firm named Aspen Labs.
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 Aspen Labs have?
Aspen Labs has 6 FDA 510(k) clearances (first 1991, latest 1997), across 4 product codes in 2 review panels.
How long does FDA take to clear Aspen Labs's 510(k)s?
The median time from FDA receipt to decision across Aspen Labs's cleared 510(k)s is 230 days.
What devices does Aspen Labs make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 2); HGI (Electrocautery, Gynecologic (And Accessories), 2); DWG (Electrosurgical Device, 1).
Has Aspen Labs had device recalls?
openFDA lists no recalls under a recalling firm name matching Aspen Labs. Related entities may recall under other names.
Next steps
- See all 6 Aspen Labs clearances with predicates and recalls
- Run predicate analysis for product code GEI, Aspen Labs'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.