Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Medical Specialties Intl., Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
112 daysmedian FDA review time
371 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972655 | CONTROL SYRINGE | Medical Specialties Intl., Inc. | 1997-11-04 | 112 | 0 |
| K972654 | MANIFOLD | Medical Specialties Intl., Inc. | 1997-10-08 | 85 | 0 |
| K952385 | HEMA-TROL Q-CHECK | Medical Specialties Intl., Inc. | 1995-09-25 | 126 | 0 |
| K940430 | SEDRATROL | Medical Specialties Intl., Inc. | 1995-02-06 | 371 | 0 |
| K895373 | HEMATOLOGY CONTROL | Medical Specialties Intl., Inc. | 1989-10-06 | 38 | 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