Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Designs, LLC · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
100 daysmedian FDA review time
219 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K182352 | SP-LINK™ System | Medical Designs, LLC | 2018-11-21 | 84 | 0 |
| K181591 | Fixated Asfora BULLET CAGE® (FABC) | Medical Designs, LLC | 2018-09-26 | 100 | 0 |
| K143688 | ASFORA ANTERIOR CERVICAL PLATE SYSTEM | Medical Designs, LLC | 2015-07-01 | 189 | 0 |
| K112648 | ASFORA BULLET CAGE | Medical Designs, LLC | 2012-03-13 | 183 | 0 |
| K090048 | ASFORA BULLET CAGE SYSTEM | Medical Designs, LLC | 2009-08-14 | 219 | 0 |
| K042359 | SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA) | Medical Designs, LLC | 2004-11-17 | 78 | 1 |
| K002970 | SUBDURAL EVACUATING PORT SYSTEM, MODEL 11-9901 | Medical Designs, LLC | 2000-12-12 | 81 | 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