Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
J & B Assoc. · Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
90 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K900526 | MODEL F 1 FLIP-UP SUNGLASSES W/POLORIZED LENS | J & B Assoc. | 1990-05-03 | 90 | 0 |
| K900529 | MODEL 9018 PC SUNGLASSES W/POLYCARBONATE LENSES | J & B Assoc. | 1990-05-03 | 90 | 0 |
| K900521 | MODEL N742 SUNGLASSES W/POLYCARBONATE BLUE BLOCKER | J & B Assoc. | 1990-05-03 | 90 | 0 |
| K900520 | MODEL N742 SUNGLASSES W/ACRYLIC NIGHT DRIVER LENS | J & B Assoc. | 1990-05-03 | 90 | 0 |
| K900527 | MODEL S139029 SUNGLASSES W/MIRROR ACRYLIC LENSES | J & B Assoc. | 1990-05-03 | 90 | 0 |
| K900522 | MODEL N741 SUNGLASSES W/ACRYLIC BLUE COMPUTER LENS | J & B Assoc. | 1990-05-03 | 90 | 0 |
| K900524 | MODEL F3 FLIP UP SUNGLASSES W/POLORIZED COMPUTER | J & B Assoc. | 1990-05-03 | 90 | 0 |
| K900528 | MODEL 8806 SD SUNGLASSES W/ACRYLIC LENSES | J & B Assoc. | 1990-05-03 | 90 | 0 |
| K900523 | MODEL F3 FLIP-UP SUNGLASSES W/ACRYLIC ORANGE COMP. | J & B Assoc. | 1990-02-27 | 25 | 0 |
| K900525 | MODEL F 1 FLIP-UP SUNGLASSES W/POLYCARBONATE BLUE | J & B Assoc. | 1990-02-27 | 25 | 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