Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sarstedt, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
135 daysmedian FDA review time
170 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K051019 | SAFETY NEEDLE | Sarstedt, Inc. | 2005-07-25 | 94 | 0 |
| K032150 | SAFETY-MULTIFLY | Sarstedt, Inc. | 2003-09-12 | 60 | 0 |
| K031359 | S-MONOVETTE EDTA K2-GEL | Sarstedt, Inc. | 2003-09-12 | 135 | 0 |
| K024237 | URINE MONOVETTE BORIC ACID | Sarstedt, Inc. | 2003-04-14 | 112 | 0 |
| K003382 | SARSTEDT NEEDLE PROTECTOR | Sarstedt, Inc. | 2001-03-30 | 150 | 0 |
| K913622 | HEMOPLUS | Sarstedt, Inc. | 1992-01-31 | 170 | 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