Medical Compression Systems (Dbn) , Ltd.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Medical Compression Systems (Dbn) , Ltd.” (first 2000, latest 2016), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 78 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 | 63 |
| 2013 | 0 | — |
| 2014 | 1 | 43 |
| 2015 | 0 | — |
| 2016 | 1 | 148 |
| 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 |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | 9 | 9 |
| IRP | Massager, Powered Inflatable Tube | 1 | 1 |
Review panels
- Cardiovascular (9)
- Physical Medicine (1)
Most recent Medical Compression Systems (Dbn) , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K160431 | ActiveCare Home | JOW | 2016-07-13 | 148 |
| K140755 | ACTIVECARE DVT, ACTIVECARE+SFT, AND ACTIVECARE+DTX SYSTEMS | JOW | 2014-05-08 | 43 |
| K113525 | ACTIVECARE DVT ACTIVECARE+SFT | JOW | 2012-01-31 | 63 |
| K110159 | ACTIVECARE SFT | JOW | 2011-05-12 | 113 |
| K060146 | ACTIVECARE ++ SYSTEM | JOW | 2006-03-08 | 48 |
| K023573 | WIZAIR COMPRESSION SYSTEM | JOW | 2002-11-21 | 28 |
| K012994 | WIZAIR DVT | JOW | 2002-03-27 | 202 |
| K002287 | WIZAIR COMPRESSION SYSTEM | JOW | 2000-08-25 | 29 |
| K993758 | PROAIR 3000 COMPRESSION SYSTEM | JOW | 2000-05-19 | 196 |
| K994057 | SLENDAIR 4000 COMPRESSION SYSTEM | IRP | 2000-03-03 | 94 |
Recalls
openFDA lists no recalls under a recalling firm named Medical Compression Systems (Dbn) , Ltd..
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.
- Medical Analysis Systems, Inc. (107 510(k)s)
- Medical Components, Inc. (63 510(k)s)
- Medical Advances, Inc. (57 510(k)s)
- Medical Diagnostic Technologies, Inc. (57 510(k)s)
- Medical Devices, Inc. (49 510(k)s)
- Medical Device Technologies, Inc. (46 510(k)s)
- Medical Specialties, Inc. (40 510(k)s)
- Medical Device Inspection Co., Inc. (30 510(k)s)
- Medical Engineering Corp. (28 510(k)s)
- Medical Data Electronics (27 510(k)s)
- Medical Graphics Corp. (25 510(k)s)
- Medical Innovations Corp. (24 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Medical Compression Systems (Dbn) , Ltd.?
FDA lists 10 510(k) clearances under the applicant name “Medical Compression Systems (Dbn) , Ltd.” (first 2000, latest 2016), 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 Medical Compression Systems (Dbn) , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Medical Compression Systems (Dbn) , Ltd. is 78 days.
Which FDA product codes appear under Medical Compression Systems (Dbn) , Ltd.?
The most frequent FDA product codes under this applicant name are JOW (Sleeve, Limb, Compressible, 9); IRP (Massager, Powered Inflatable Tube, 1).
Next steps
- See all 10 Medical Compression Systems (Dbn) , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code JOW, Medical Compression Systems (Dbn) , Ltd.'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.