Aspen Laboratories, Inc.: FDA filings under this applicant name
FDA lists 55 510(k) clearances under the applicant name “Aspen Laboratories, Inc.” (first 1976, latest 1998), across 15 product codes in 8 review panels. Median 510(k) review time under this name: 39 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under CONMED, based on public ownership records.
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 | 24 | 24 |
| EQH | Source, Carrier, Fiberoptic Light | 10 | 10 |
| KCY | Tourniquet, Pneumatic | 5 | 5 |
| DRX | Electrode, Electrocardiograph | 2 | 2 |
| FCT | Headlight, Fiberoptic Focusing | 2 | 2 |
| HBI | Illuminator, Fiberoptic, Surgical Field | 2 | 2 |
| DZI | Drill, Bone, Powered | 1 | 1 |
| FQM | Bandage, Elastic | 1 | 1 |
| FSE | Table, Operating-Room, Manual | 1 | 1 |
| FWF | Camera, Television, Endoscopic, Without Audio | 1 | 1 |
Plus 5 more product codes.
Review panels
- General and Plastic Surgery (35)
- Ear, Nose and Throat (10)
- Cardiovascular (2)
- Ophthalmic (2)
- Dental (1)
- General Hospital (1)
- Obstetrics and Gynecology (1)
- Orthopedic (1)
Most recent Aspen Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K981220 | SYSTEM 7500 ABC ELECTROSURGICAL UNIT | GEI | 1998-04-21 | 18 |
| K963088 | SHEATH, ELECTROSURGICAL PENCIL | GEI | 1996-09-13 | 36 |
| K955834 | SYSTEM 6500 ABC ELECTROSURGICAL UNIT | GEI | 1996-07-11 | 198 |
| K960296 | 4000 ETM | GEI | 1996-02-20 | 29 |
| K953081 | BEAMER PLUS | GEI | 1995-10-30 | 119 |
| K953007 | EXCALIBUR PLUS ELECTROSURGICAL UNIT | GEI | 1995-08-21 | 54 |
| K946104 | SMOKIEVAC ELECTROSURGICAL PENCIL | GEI | 1995-04-03 | 110 |
| K944012 | ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATOR | GEI | 1994-12-21 | 127 |
| K924960 | EXCALIBUR ELECTROSURGICAL UNIT | GEI | 1993-04-16 | 198 |
| K913213 | SINGLE USE LEE ELECTRODE | HGI | 1992-02-13 | 209 |
45 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Aspen Laboratories, 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.
- Aspen Labs (6 510(k)s)
- Aspen Glove Sdn. Bhd. (4 510(k)s)
- Aspen Imaging Healthcare, Inc. (2 510(k)s)
- Aspen Laser Systems, LLC (2 510(k)s)
- Aspen Surgical Products, Inc. (2 510(k)s)
- Aspen Medical , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Aspen Laboratories, Inc.?
FDA lists 55 510(k) clearances under the applicant name “Aspen Laboratories, Inc.” (first 1976, latest 1998), across 15 product codes in 8 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 Aspen Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Aspen Laboratories, Inc. is 39 days.
Which FDA product codes appear under Aspen Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 24); EQH (Source, Carrier, Fiberoptic Light, 10); KCY (Tourniquet, Pneumatic, 5).
Next steps
- See all 55 Aspen Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Aspen Laboratories, 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.