Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sparco, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
35 daysmedian FDA review time
82 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K884041 | MASTER-GUARD | Sparco, Inc. | 1988-10-07 | 11 | 0 |
| K863964 | LIMB-GUARD | Sparco, Inc. | 1986-10-24 | 14 | 0 |
| K850268 | SPARCO SCOPE GUARD | Sparco, Inc. | 1985-04-15 | 82 | 0 |
| K850267 | SPARCO PIGGY-BACK POLE-INTRAVENOUS TRANSPORT POLE | Sparco, Inc. | 1985-02-27 | 35 | 0 |
| K844286 | FLASH GUARD PLASTIC VERSION | Sparco, Inc. | 1984-11-19 | 14 | 0 |
| K841669 | FLASH GUARD | Sparco, Inc. | 1984-06-05 | 43 | 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