Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
International Regulatory Consultants · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
158 daysmedian FDA review time
350 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K981591 | VORTEK URETERAL DOUBLE LOOP STENT, BIOSOFT URETERAL DOUBLE L | International Regulatory Consultants | 1998-10-09 | 158 | 0 |
| K971347 | MEDISURF | International Regulatory Consultants | 1997-07-03 | 84 | 0 |
| K962614 | SHIFA STERILE DISPOSABLE SYRINGES | International Regulatory Consultants | 1996-09-06 | 65 | 0 |
| K950012 | DISPOMEDIC DISPOSABLE SYRINGES AND NEEDLES | International Regulatory Consultants | 1995-08-18 | 227 | 0 |
| K935280 | MEMOTHERM 10 BABY THERMOMETER | International Regulatory Consultants | 1994-10-19 | 350 | 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