Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Medical Product Specialists · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K982587 | MPS FIXED FLOW RATE SET | Medical Product Specialists | 1998-08-24 | 31 | 0 |
| K982048 | MPS RESERVOIR BAG | Medical Product Specialists | 1998-07-27 | 47 | 0 |
| K982047 | MPS HUBER NEEDLE EXTENSION SET | Medical Product Specialists | 1998-07-21 | 41 | 0 |
| K895367 | INTRAVENOUS EXTENSION SET | Medical Product Specialists | 1989-10-06 | 39 | 6 |
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