Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sparta Surgical Corp. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
220 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K965187 | SPECTRUM II, SPECTRUM PLUS, AND SPECTRUM MAX-SD | Sparta Surgical Corp. | 1997-08-01 | 220 | 0 |
| K945313 | SPARTA HYDROGEL WOUND DRESSING | Sparta Surgical Corp. | 1995-01-12 | 72 | 0 |
| K922729 | SPARTA WET DRESSING, SODIUM CHLORIDE | Sparta Surgical Corp. | 1992-11-23 | 171 | 0 |
| K905384 | DAVID SIMMONDS ANESTHESIA EXTENSION TUBES | Sparta Surgical Corp. | 1991-03-22 | 113 | 0 |
| K905240 | VESSELOOPS | Sparta Surgical Corp. | 1991-02-06 | 78 | 0 |
| K896085 | SURGI-BRUSH | Sparta Surgical Corp. | 1989-11-08 | 20 | 0 |
| K896084 | MICROSPEARS | Sparta Surgical Corp. | 1989-11-02 | 14 | 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