Medicon, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Medicon, Inc.” (first 1981, latest 2012), across 14 product codes in 8 review panels. Median 510(k) review time under this name: 65 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 | 293 |
| 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 |
|---|---|---|---|
| EFQ | Gauze/Sponge, Internal | 2 | 2 |
| BZQ | Monitor, Breathing Frequency | 1 | 1 |
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | 1 | 1 |
| FLS | Monitor, Apnea, Facility Use | 1 | 1 |
| FPP | Stretcher, Hand-Carried | 1 | 1 |
| FXP | Cover, Shoe, Operating-Room | 1 | 1 |
| FYA | Gown, Surgical | 1 | 1 |
| FYF | Cap, Surgical | 1 | 1 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | 1 | 1 |
Plus 4 more product codes.
Review panels
- General and Plastic Surgery (4)
- General Hospital (3)
- Anesthesiology (2)
- Physical Medicine (2)
- Cardiovascular (1)
- Dental (1)
- Neurology (1)
- Orthopedic (1)
Most recent Medicon, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K111341 | CLEANE / CLEANE POP | OZC | 2012-02-29 | 293 |
| K962087 | SERVOTRONIC EC100 SYSTEM | HWE | 1997-04-23 | 330 |
| K952168 | TITANIUM MANDIBULAR FRACTURE SYSTEM | JEY | 1995-06-22 | 45 |
| K850855 | TENS GB1001 DEVICE | GZJ | 1986-01-09 | 314 |
| K850852 | INFRARAX DEVICE | ILY | 1985-08-21 | 173 |
| K844702 | GAUZE ASORBABLE | EFQ | 1985-04-01 | 119 |
| K844573 | ABSORBABLE GAUZE PRODUCTS | EFQ | 1985-03-05 | 102 |
| K844574 | WHEELCHAIRS | IOR | 1985-02-21 | 90 |
| K844705 | SHOE COVERS | FXP | 1985-01-10 | 38 |
| K844704 | CAPS (O.R. NURSE, SURGICAL) | FYF | 1985-01-10 | 38 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Medicon, 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.
- Medicon EG (17 510(k)s)
- Medicon Instruments, Inc. (6 510(k)s)
- Medicon Hellas S.A (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medicon, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Medicon, Inc.” (first 1981, latest 2012), across 14 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 Medicon, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medicon, Inc. is 65 days.
Which FDA product codes appear under Medicon, Inc.?
The most frequent FDA product codes under this applicant name are EFQ (Gauze/Sponge, Internal, 2); BZQ (Monitor, Breathing Frequency, 1); DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm), 1).
Next steps
- See all 15 Medicon, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EFQ, Medicon, 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.