Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Equipment Development Co., Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
531 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K911973 | LINEAR ACCELERATOR COLLIMATOR | Medical Equipment Development Co., Inc. | 1992-10-15 | 531 | 0 |
| K901670 | GNOMOS STEREOTACTIC DEVICE | Medical Equipment Development Co., Inc. | 1990-07-03 | 84 | 0 |
| K895537 | MODIFIED MEMORY RETRACTOR ARM | Medical Equipment Development Co., Inc. | 1989-09-22 | 10 | 0 |
| K893911 | MED-TECH RADIOLUCENT HEAD FIXATION SYSTEM | Medical Equipment Development Co., Inc. | 1989-08-29 | 91 | 0 |
| K874829 | MEDCO MEMORY RETRACTOR SYSTEM | Medical Equipment Development Co., Inc. | 1988-03-24 | 121 | 0 |
| K874833 | ARC ADAPTER ASSEMBLY | Medical Equipment Development Co., Inc. | 1988-03-03 | 100 | 0 |
| K802399 | MODEL 2500 PNEUMATIC PERCUSSOR | Medical Equipment Development Co., Inc. | 1980-10-23 | 21 | 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