Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
IPS — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
15 daysmedian FDA review time
28 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K832970 | CANE REACHER | Maddak, Inc. | 1983-09-29 | 28 | 0 |
| K832969 | WALKING CANE | Maddak, Inc. | 1983-09-29 | 28 | 0 |
| K821402 | LIGHT WEIGHT ALUMINUM CANES | Manuco Manufacturing Co., Inc. | 1982-04-21 | 0 | 0 |
| K790558 | CERSA-CANE | Maddak, Inc. | 1979-04-03 | 15 | 0 |
| K790561 | OFFSET ALUMINUM CANE | Maddak, Inc. | 1979-04-03 | 15 | 0 |
| K790299 | FOREARM-CANE | Guardian Products Co., Inc. | 1979-02-21 | 9 | 0 |
| K780085 | CANE/REACHER | Fred Sammons, Inc. | 1978-01-30 | 14 | 0 |
| K772267 | QUADRAPLEGIC WALKING AID | Med Fusion Systems, Inc. | 1977-12-20 | 11 | 0 |
| K770529 | UNICET I | Union Carbide Corp. | 1977-04-05 | 15 | 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