Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Del Medical Systems Corp. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
97 daysmedian FDA review time
252 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K962684 | S-357 VIDEO IMAGING SYSTEM | Del Medical Systems Corp. | 1996-10-15 | 97 | 0 |
| K962651 | S-52 ELECTRONIC VIDEO LAPAROSCOPE | Del Medical Systems Corp. | 1996-09-30 | 84 | 0 |
| K960301 | ND VISION-220 ADAPTIVE IMAGE PROCESSESSOR | Del Medical Systems Corp. | 1996-09-30 | 252 | 0 |
| K962979 | S-53 INTRORAL DENTAL SYSTEM | Del Medical Systems Corp. | 1996-09-25 | 56 | 0 |
| K962020 | S-41 & S-41S VIDEO IMAGING SYSTEM | Del Medical Systems Corp. | 1996-08-30 | 99 | 0 |
| K962024 | S-57 VIDEO IMAGING SYSTEM | Del Medical Systems Corp. | 1996-07-09 | 47 | 0 |
| K942924 | MSV-2000 VIDEO IMAGING SYSTEM | Del Medical Systems Corp. | 1994-10-03 | 103 | 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