Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Intl. Medical Consultants · Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
244 daysmedian FDA review time
253 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K930927 | DURHAM;T ADAPTOR EXTENSIONSET W/INJECTION SITE | Intl. Medical Consultants | 1993-11-03 | 253 | 0 |
| K930974 | DURHAM; INJECTION SITE EXTENSION SET, LUER LOCK | Intl. Medical Consultants | 1993-11-03 | 252 | 0 |
| K931119 | DURHAM; NON CORING WINGED ADMINISTRATION SET | Intl. Medical Consultants | 1993-11-03 | 244 | 0 |
| K930926 | DURHAM; Y CHECK SET-LUER LOCK W/INJECTION SITE | Intl. Medical Consultants | 1993-10-12 | 231 | 0 |
| K930750 | DURHAM; ADM. SET-LUER LOCK W/.22 MICRON FILTER | Intl. Medical Consultants | 1993-09-03 | 203 | 0 |
| K930751 | DURHAM; EXTENSION TUBE LUER LOCK W/INJECTION SITE | Intl. Medical Consultants | 1993-09-03 | 203 | 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