Cleveland Medical Devices, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Cleveland Medical Devices, Inc.” (first 1995, latest 2007), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 94 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 | 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 |
|---|---|---|---|
| OMC | Reduced- Montage Standard Electroencephalograph | 3 | 3 |
| GYD | Transducer, Tremor | 1 | 1 |
| IKE | Transducer, Miniature Pressure | 1 | 1 |
| IRN | Device, Warning, Overload, External Limb, Powered | 1 | 1 |
| KNX | Collector, Urine, (And Accessories) For Indwelling Catheter | 1 | 1 |
| OLV | Standard Polysomnograph With Electroencephalograph | 1 | 1 |
Review panels
Most recent Cleveland Medical Devices, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K063872 | KINESIA | GYD | 2007-04-06 | 98 |
| K042039 | FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120 | OLV | 2004-11-17 | 111 |
| K013863 | CRYSTAL MONITOR MODEL 16 | OMC | 2002-02-19 | 90 |
| K001110 | CRYSTAL-EEG MODEL 15 | OMC | 2000-07-05 | 90 |
| K970672 | CRYSTAL-EEG MODEL 10 (MODEL 10) | OMC | 1997-05-22 | 87 |
| K964690 | LIBERTY VALVE | KNX | 1997-03-21 | 119 |
| K962591 | FOOT WEIGHT ALARM | IRN | 1996-12-04 | 155 |
| K954670 | PRESSORE MONITOR | IKE | 1995-10-30 | 20 |
Recalls
openFDA lists no recalls under a recalling firm named Cleveland Medical Devices, 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.
Device clinical trials
An industry sponsor named Cleveland Medical Devices, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT02200523: Self Abrading Rapidly Applied Electrode Validation (Completed, started 2014-06)
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.
- Cleveland Tubing, Inc. (4 510(k)s)
- Cleveland Clinic (1 510(k)s)
- Cleveland Clinic Foundation (1 510(k)s)
- Cleveland Medical Supply & Services (1 510(k)s)
- Cleveland Diagnostics, Inc. (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cleveland Medical Devices, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Cleveland Medical Devices, Inc.” (first 1995, latest 2007), across 6 product codes in 3 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 Cleveland Medical Devices, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cleveland Medical Devices, Inc. is 94 days.
Which FDA product codes appear under Cleveland Medical Devices, Inc.?
The most frequent FDA product codes under this applicant name are OMC (Reduced- Montage Standard Electroencephalograph, 3); GYD (Transducer, Tremor, 1); IKE (Transducer, Miniature Pressure, 1).
Next steps
- See all 8 Cleveland Medical Devices, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OMC, Cleveland Medical Devices, 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.