Cher Mel Corp.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Cher Mel Corp.” (first 1984, latest 1986), across 6 product codes in 3 review panels. Median 510(k) review time under this name: 80 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 |
|---|---|---|---|
| LDE | Stethoscope, Manual | 2 | 2 |
| FPA | Set, Administration, Intravascular | 1 | 1 |
| GDH | Gouge, Surgical, General & Plastic Surgery | 1 | 1 |
| GFI | Osteotome, Manual | 1 | 1 |
| KDG | Chisel (Osteotome) | 1 | 1 |
| KPE | Container, I.V. | 1 | 1 |
Review panels
Most recent Cher Mel Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K863040 | DISPOSABLE INTRAVENOUS HYPERALIMENTATION BAGS | KPE | 1986-10-31 | 80 |
| K851516 | CHERMEL SCALP VEIN SET | FPA | 1985-08-23 | 130 |
| K843324 | SPRAGUE RAPPAPORT/SH-6008 DISPOS. STETH | LDE | 1985-06-06 | 286 |
| K842203 | LITTMAN TYPE SH-6010, NURSE TYPE | LDE | 1985-06-06 | 367 |
| K842824 | CHERMEL BONE CHISELS | KDG | 1984-08-02 | 14 |
| K842823 | CHERMEL OSTEOTOMES | GFI | 1984-08-02 | 14 |
| K842822 | CHERMEL BONE GOUGES | GDH | 1984-08-02 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Cher Mel Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Cher Mel Corp.?
FDA lists 7 510(k) clearances under the applicant name “Cher Mel Corp.” (first 1984, latest 1986), across 6 product codes in 3 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 Cher Mel Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cher Mel Corp. is 80 days.
Which FDA product codes appear under Cher Mel Corp.?
The most frequent FDA product codes under this applicant name are LDE (Stethoscope, Manual, 2); FPA (Set, Administration, Intravascular, 1); GDH (Gouge, Surgical, General & Plastic Surgery, 1).
Next steps
- See all 7 Cher Mel Corp. clearances with predicates and recalls
- Run predicate analysis for product code LDE, Cher Mel Corp.'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.