Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Equipment Device Specialists · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
93 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K040193 | MODEL GST-1 | Medical Equipment Device Specialists | 2004-04-27 | 90 | 0 |
| K032055 | MEDS-4-INF+ | Medical Equipment Device Specialists | 2003-10-03 | 93 | 0 |
| K023446 | MEDS-3 NEUROMUSCULAR STIMULATOR | Medical Equipment Device Specialists | 2003-01-13 | 90 | 0 |
| K023439 | MEDS-4 NEUROMUSCULAR STIMULATOR | Medical Equipment Device Specialists | 2003-01-13 | 90 | 0 |
| K023443 | MEDS-3 NEUROMUSCULAR STIMULATOR | Medical Equipment Device Specialists | 2003-01-13 | 90 | 0 |
| K023435 | MEDS-4 NEUROMUSCULAR STIMULATOR | Medical Equipment Device Specialists | 2003-01-13 | 90 | 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