Compression Therapy Concepts, Inc.: FDA clearances and approvals
Compression Therapy Concepts, Inc. has 8 FDA 510(k) clearances (first 2000, latest 2012), across 1 product code in 1 review panel. Median 510(k) review time: 59 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 28 |
| 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 |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | 8 | 8 |
Review panels
- Cardiovascular (8)
Most recent Compression Therapy Concepts, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122179 | VASOPRESS DVT LEG GARMENTS (STERILE) VASOPRESS DVT FOOT GARMENTS (STERILE) | JOW | 2012-08-20 | 28 |
| K112838 | VASOPRESS REPROCESSED DVT LEG / FOOT GARMENTS | JOW | 2011-11-10 | 43 |
| K102940 | VASCOPRESS SEQUENTIAL DVT PUMP | JOW | 2011-01-20 | 108 |
| K102732 | VASOGRAD DVT COMPRESSION GARMENT | JOW | 2010-10-19 | 27 |
| K101915 | VASOPRESS SUPREME MINI MODEL VP500DM | JOW | 2010-08-06 | 28 |
| K061814 | VASOPRESS DVT SYSTEM, MODEL VP500D | JOW | 2006-11-30 | 156 |
| K061967 | SCD GARMENT, MODEL VP530 | JOW | 2006-09-25 | 75 |
| K000147 | CTC DVT-1 CALF GARMENT, MODEL DVT-1 | JOW | 2000-04-13 | 86 |
Recalls
openFDA lists no recalls under a recalling firm named Compression Therapy Concepts, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Compression Therapy Concepts, Inc. have?
Compression Therapy Concepts, Inc. has 8 FDA 510(k) clearances (first 2000, latest 2012), across 1 product code in 1 review panel.
How long does FDA take to clear Compression Therapy Concepts, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Compression Therapy Concepts, Inc.'s cleared 510(k)s is 59 days.
What devices does Compression Therapy Concepts, Inc. make?
Its most frequent FDA product codes are JOW (Sleeve, Limb, Compressible, 8).
Has Compression Therapy Concepts, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Compression Therapy Concepts, Inc. Related entities may recall under other names.
Next steps
- See all 8 Compression Therapy Concepts, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JOW, Compression Therapy Concepts, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.