Bio Compression Systems, Inc.: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Bio Compression Systems, Inc.” (first 1996, latest 2026), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 95 days. Since 2017 the median was 102 days, against 133 days for all cleared 510(k)s in the same product codes. 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 | 3 | 76 |
| 2014 | 1 | 50 |
| 2015 | 1 | 98 |
| 2016 | 0 | — |
| 2017 | 1 | 62 |
| 2018 | 1 | 190 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 92 |
| 2022 | 1 | 103 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 1 | 256 |
| 2026 | 1 | 102 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Bio Compression Systems, Inc. took a median 102 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 133 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | 12 | 12 |
| IRP | Massager, Powered Inflatable Tube | 3 | 3 |
| ILO | Pack, Hot Or Cold, Water Circulating | 1 | 1 |
Review panels
- Cardiovascular (12)
- Physical Medicine (4)
Most recent Bio Compression Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261807 | Sequential Circulator (SC-4004-DL, SC-4008-DL) | JOW | 2026-09-11 | 102 |
| K250974 | Bio Arterial Deluxe (IC-BAP-DX) | JOW | 2025-12-12 | 256 |
| K213533 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL | IRP | 2022-02-16 | 103 |
| K210417 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, SC-2008-DL, SC-4004-DL, SC-4008-DL | JOW | 2021-05-14 | 92 |
| K180248 | VascuEase IC-1200-WH | JOW | 2018-08-07 | 190 |
| K171793 | Sequential Circulator SC-2004FC-OC | JOW | 2017-08-17 | 62 |
| K150953 | Sequential Circulator SC-2008-OC, Sequential Circulator SC-2004-OC | JOW | 2015-07-16 | 98 |
| K142640 | Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL Sequenstial Circulator, Model SC-2008-DL Sequential Circulator, Model SC-3008-DL Sequential Circulator | JOW | 2014-11-06 | 50 |
| K131306 | IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRESSION DEVICE | JOW | 2013-07-22 | 76 |
| K131327 | BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM | JOW | 2013-07-18 | 71 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bio Compression Systems, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Bio Compression Systems, Inc.?
FDA lists 16 510(k) clearances under the applicant name “Bio Compression Systems, Inc.” (first 1996, latest 2026), across 3 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 Bio Compression Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bio Compression Systems, Inc. is 95 days. Since 2017: 102 days, versus 133 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Bio Compression Systems, Inc.?
The most frequent FDA product codes under this applicant name are JOW (Sleeve, Limb, Compressible, 12); IRP (Massager, Powered Inflatable Tube, 3); ILO (Pack, Hot Or Cold, Water Circulating, 1).
Next steps
- See all 16 Bio Compression Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JOW, Bio Compression Systems, 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.