Cost Rite Health Products, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Cost Rite Health Products, Inc.” (first 1987, latest 1989), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 46 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | 2 | 2 |
| FXX | Mask, Surgical | 2 | 2 |
| EFW | Toothbrush, Manual | 1 | 1 |
| EIE | Dam, Rubber | 1 | 1 |
| JES | Floss, Dental | 1 | 1 |
Review panels
- General Hospital (4)
- Dental (3)
Most recent Cost Rite Health Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K891141 | CARERITE FACE MASK | FXX | 1989-04-18 | 46 |
| K890667 | RUBBER DAM | EIE | 1989-03-29 | 48 |
| K873705 | CARERITE FACE MASK | FXX | 1987-10-05 | 21 |
| K871798 | FILM AND PAPER COMBINATION STERILIZING BAG | FRG | 1987-07-21 | 75 |
| K871736 | CARERITE BIOPACK GINGIVAL RETRACTION CORD | JES | 1987-05-27 | 22 |
| K870147 | CARERITE & COST RITE NYLON STERILIZATION FILM | FRG | 1987-04-23 | 100 |
| K870906 | CARERITE INTERDENTAL BRUSHES, MODELS 3500 & 4500 | EFW | 1987-03-30 | 25 |
Recalls
openFDA lists no recalls under a recalling firm named Cost Rite Health Products, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Cost Reduction Technologies, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cost Rite Health Products, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Cost Rite Health Products, Inc.” (first 1987, latest 1989), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cost Rite Health Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cost Rite Health Products, Inc. is 46 days.
Which FDA product codes appear under Cost Rite Health Products, Inc.?
The most frequent FDA product codes under this applicant name are FRG (Wrap, Sterilization, 2); FXX (Mask, Surgical, 2); EFW (Toothbrush, Manual, 1).
Next steps
- See all 7 Cost Rite Health Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRG, Cost Rite Health Products, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.