Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Compression Systems (Dbn) , Ltd. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
94 daysmedian FDA review time
202 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K160431 | ActiveCare Home | Medical Compression Systems (Dbn) , Ltd. | 2016-07-13 | 148 | 0 |
| K140755 | ACTIVECARE DVT, ACTIVECARE+SFT, AND ACTIVECARE+DTX SYSTEMS | Medical Compression Systems (Dbn) , Ltd. | 2014-05-08 | 43 | 0 |
| K113525 | ACTIVECARE DVT ACTIVECARE+SFT | Medical Compression Systems (Dbn) , Ltd. | 2012-01-31 | 63 | 0 |
| K110159 | ACTIVECARE SFT | Medical Compression Systems (Dbn) , Ltd. | 2011-05-12 | 113 | 0 |
| K060146 | ACTIVECARE ++ SYSTEM | Medical Compression Systems (Dbn) , Ltd. | 2006-03-08 | 48 | 1 |
| K023573 | WIZAIR COMPRESSION SYSTEM | Medical Compression Systems (Dbn) , Ltd. | 2002-11-21 | 28 | 1 |
| K012994 | WIZAIR DVT | Medical Compression Systems (Dbn) , Ltd. | 2002-03-27 | 202 | 0 |
| K002287 | WIZAIR COMPRESSION SYSTEM | Medical Compression Systems (Dbn) , Ltd. | 2000-08-25 | 29 | 0 |
| K993758 | PROAIR 3000 COMPRESSION SYSTEM | Medical Compression Systems (Dbn) , Ltd. | 2000-05-19 | 196 | 0 |
| K994057 | SLENDAIR 4000 COMPRESSION SYSTEM | Medical Compression Systems (Dbn) , Ltd. | 2000-03-03 | 94 | 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