Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Kaye Products, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
22 daysmedian FDA review time
37 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K924848 | KAYE SCOOT-ABOUT, MODEL SB1 | Kaye Products, Inc. | 1993-02-12 | 137 | 0 |
| K923095 | KAYE MODEL KIAO PELVIC/THIGH STABILIZER | Kaye Products, Inc. | 1992-07-21 | 26 | 0 |
| K922061 | CHAIR, ADJUSTABLE, MECHANICAL | Kaye Products, Inc. | 1992-05-26 | 22 | 0 |
| K885330 | WHEELCHAIR, MECHANICAL | Kaye Products, Inc. | 1989-02-03 | 37 | 0 |
| K833869 | CHILD'S WALKER | Kaye Products, Inc. | 1983-11-29 | 21 | 0 |
| K830560 | EXERCISER, PASSIVE, NON MEASURING | Kaye Products, Inc. | 1983-03-09 | 14 | 0 |
| K830466 | BARS, PARALLEL, EXERCISE | Kaye Products, Inc. | 1983-03-09 | 22 | 0 |
| K820591 | MECHANICAL CHAIR | Kaye Products, Inc. | 1982-03-15 | 11 | 0 |
| K812399 | CHAIR, ADJUSTABLE, MECHANICAL | Kaye Products, Inc. | 1981-09-14 | 25 | 0 |
| K812319 | THERAPY BENCH | Kaye Products, Inc. | 1981-08-31 | 14 | 0 |
| K810609 | PEDIATRIC POSITION HOLDER | Kaye Products, Inc. | 1981-03-20 | 14 | 0 |
| K791423 | TOILET TRAINER FOR HANDICAPPED CHILD | Kaye Products, Inc. | 1979-08-10 | 10 | 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