Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Concepts Development, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
209 daysmedian FDA review time
439 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K020581 | COLOSHIELD COLONOSCOPY DRAPE MODEL E2000 | Medical Concepts Development, Inc. | 2002-09-18 | 209 | 0 |
| K000442 | ACTI-GARD ANTIMICROBIAL FILM, MODELS D6635, D6640, D6648, D6 | Medical Concepts Development, Inc. | 2001-04-24 | 439 | 0 |
| K924794 | TRANSPARENT ADHESIVE DRESSING | Medical Concepts Development, Inc. | 1993-07-08 | 288 | 0 |
| K870044 | MCD SPECIALTY BRAND NEEDLE COUNTERS | Medical Concepts Development, Inc. | 1987-01-21 | 16 | 0 |
| K861530 | SURGICAL PACKS, KITS AND TRAYS | Medical Concepts Development, Inc. | 1986-05-30 | 36 | 0 |
| K861531 | DISPOSABLE SURGICAL DRAPES AND ACCESSORIES | Medical Concepts Development, Inc. | 1986-05-23 | 29 | 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