Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Select Sources, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
104 daysmedian FDA review time
194 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K884328 | CHOICE ALSO ORIENT SURGICAL GLOVES (STERILE) | Select Sources, Inc. | 1989-04-26 | 194 | 0 |
| K883705 | FACE MASK: COMAS ALSO CHOICE/CONE MASK: POLYMAS | Select Sources, Inc. | 1988-11-14 | 76 | 0 |
| K883078 | INSULIN SYRINGE | Select Sources, Inc. | 1988-10-31 | 104 | 0 |
| K883033 | PISTON SYRINGE WITH NEEDLE | Select Sources, Inc. | 1988-10-31 | 104 | 0 |
| K880919 | (CHOICE) ALSO (KONDUM) | Select Sources, Inc. | 1988-06-29 | 117 | 0 |
| K864482 | CHOICE | Select Sources, Inc. | 1986-12-22 | 39 | 0 |
| K863190 | CHOICE CONDOM | Select Sources, Inc. | 1986-12-03 | 106 | 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