Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LWG — Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K883295 | CHOP SPINE FRAME | Avec Scientific Design Corp. | 1988-08-23 | 19 | 0 |
| K882520 | SHOULDER BOLSTER, KNEE, ANKLE & LEG SUPPORT PADS | Karlin Technology, Inc. | 1988-07-18 | 31 | 0 |
| K874494 | KAMBIN LAMINECTOMY FRAME | Avec Scientific Design Corp. | 1987-11-23 | 21 | 0 |
| K873690 | CEDAR(TM) PELVIC CUSHION | Cedar Surgical, Inc. | 1987-10-26 | 48 | 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