Olsen Medical: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Olsen Medical” (first 2005, latest 2013), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 189 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 | 1 | 384 |
| 2013 | 1 | 269 |
| 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 | 4 | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
Review panels
Most recent Olsen Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K130669 | SINGLE USE & MULTI USE BIPOLAR FORCEPS / SINGLE USE & MULTI USE MONOPOLAR FORCEPS | GEI | 2013-12-06 | 269 |
| K111262 | ELECTROSURGICAL MONOPOLAR CABLE/ADAPTERS, ELECTROSURGICAL BIPOLAR CABLE/ ADAPTERS, BIPOLAR ELECTROSURGICAL CABLES, MONOP | GEI | 2012-05-23 | 384 |
| K080187 | OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS | GEI | 2008-05-09 | 105 |
| K072937 | OLSEN MEDICAL INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET | GEI | 2007-12-28 | 73 |
| K042073 | OLSEN MEDICAL ANTERIOR CERVICAL VERTEBRAE PLATE SYSTEM | KWQ | 2005-02-07 | 189 |
Recalls
6 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2018-05-11.
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.
- Olsen Electrosurgical, Inc. (11 510(k)s)
- Olsen Electro-Surgical Instruments, Inc. (3 510(k)s)
- Olsen Industria E Comercio S.A. (1 510(k)s)
- Olsen Indústria E Comércio S.A. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Olsen Medical?
FDA lists 5 510(k) clearances under the applicant name “Olsen Medical” (first 2005, latest 2013), across 2 product codes in 2 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 Olsen Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Olsen Medical is 189 days.
Which FDA product codes appear under Olsen Medical?
The most frequent FDA product codes under this applicant name are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 4); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 1).
Next steps
- See all 5 Olsen Medical clearances with predicates and recalls
- Run predicate analysis for product code GEI, Olsen Medical'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.