Kaye Products, Inc.: FDA clearances and approvals
Kaye Products, Inc. has 12 FDA 510(k) clearances (first 1979, latest 1993), across 10 product codes in 2 review panels. Median 510(k) review time: 22 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| INN | Chair, Adjustable, Mechanical | 3 | 3 |
| FRP | Holder, Infant Position | 1 | 1 |
| ILS | Adaptor, Hygiene | 1 | 1 |
| INM | Chair, With Casters | 1 | 1 |
| IOD | Components, Exercise | 1 | 1 |
| IOE | Bars, Parallel, Exercise | 1 | 1 |
| ION | Exerciser, Non-Measuring | 1 | 1 |
| IOR | Wheelchair, Mechanical | 1 | 1 |
| ITJ | Walker, Mechanical | 1 | 1 |
| LBE | Stroller, Adaptive | 1 | 1 |
Review panels
- Physical Medicine (11)
- General Hospital (1)
Most recent Kaye Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K924848 | KAYE SCOOT-ABOUT, MODEL SB1 | INM | 1993-02-12 | 137 |
| K923095 | KAYE MODEL KIAO PELVIC/THIGH STABILIZER | INN | 1992-07-21 | 26 |
| K922061 | CHAIR, ADJUSTABLE, MECHANICAL | INN | 1992-05-26 | 22 |
| K885330 | WHEELCHAIR, MECHANICAL | IOR | 1989-02-03 | 37 |
| K833869 | CHILD'S WALKER | ITJ | 1983-11-29 | 21 |
| K830560 | EXERCISER, PASSIVE, NON MEASURING | ION | 1983-03-09 | 14 |
| K830466 | BARS, PARALLEL, EXERCISE | IOE | 1983-03-09 | 22 |
| K820591 | MECHANICAL CHAIR | LBE | 1982-03-15 | 11 |
| K812399 | CHAIR, ADJUSTABLE, MECHANICAL | INN | 1981-09-14 | 25 |
| K812319 | THERAPY BENCH | IOD | 1981-08-31 | 14 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Kaye Products, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Kaye Products, Inc. have?
Kaye Products, Inc. has 12 FDA 510(k) clearances (first 1979, latest 1993), across 10 product codes in 2 review panels.
How long does FDA take to clear Kaye Products, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Kaye Products, Inc.'s cleared 510(k)s is 22 days.
What devices does Kaye Products, Inc. make?
Its most frequent FDA product codes are INN (Chair, Adjustable, Mechanical, 3); FRP (Holder, Infant Position, 1); ILS (Adaptor, Hygiene, 1).
Has Kaye Products, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Kaye Products, Inc. Related entities may recall under other names.
Next steps
- See all 12 Kaye Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code INN, Kaye Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.