Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bio Compression Systems, Inc. — Predicate Candidate Screening
15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
92 daysmedian FDA review time
256 days90th percentile
15clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250974 | Bio Arterial Deluxe (IC-BAP-DX) | Bio Compression Systems, Inc. | 2025-12-12 | 256 | 0 |
| K213533 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, S | Bio Compression Systems, Inc. | 2022-02-16 | 103 | 0 |
| K210417 | Sequential Circulators SC-1004-DL, SC-1008-DL, SC-2004-DL, S | Bio Compression Systems, Inc. | 2021-05-14 | 92 | 0 |
| K180248 | VascuEase IC-1200-WH | Bio Compression Systems, Inc. | 2018-08-07 | 190 | 0 |
| K171793 | Sequential Circulator SC-2004FC-OC | Bio Compression Systems, Inc. | 2017-08-17 | 62 | 0 |
| K150953 | Sequential Circulator SC-2008-OC, Sequential Circulator SC-2 | Bio Compression Systems, Inc. | 2015-07-16 | 98 | 0 |
| K142640 | Model SC-3004-DL Sequential Circulator, Model SC-3004FC-DL S | Bio Compression Systems, Inc. | 2014-11-06 | 50 | 0 |
| K131306 | IC-1545-DL MULTI FLO DVT COMBO INTERMITTENT PNEUMATIC COMPRE | Bio Compression Systems, Inc. | 2013-07-22 | 76 | 0 |
| K131327 | BIOARTERIAL PLUS ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM | Bio Compression Systems, Inc. | 2013-07-18 | 71 | 0 |
| K122112 | 2004-OC MASSAGE SYSTEM, 2008-OC MASSAGE SYSTEM | Bio Compression Systems, Inc. | 2013-04-09 | 266 | 0 |
| K072666 | BIOARTERIAL PLUS, ARTERIAL BLOOD FLOW ENHANCEMENT SYSTEM | Bio Compression Systems, Inc. | 2007-11-05 | 45 | 0 |
| K061857 | MODEL MULTI-FLO IC-1545-KT/-F INTERMITTENT CIRCULATOR | Bio Compression Systems, Inc. | 2006-08-01 | 32 | 0 |
| K043423 | MODEL SC-3008 SEQUENTIAL CIRCULATOR | Bio Compression Systems, Inc. | 2005-02-01 | 50 | 0 |
| K961426 | BIO BOOST | Bio Compression Systems, Inc. | 1996-10-28 | 199 | 0 |
| K961425 | BIO COMPRESSION COLD FLO, SINGLE CHAMBER INTERMITTENT AND MU | Bio Compression Systems, Inc. | 1996-10-28 | 199 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda