Crystal Medical Products, Inc.: FDA clearances and approvals
Crystal Medical Products, Inc. has 5 FDA 510(k) clearances (first 1984, latest 1986), across 2 product codes in 1 review panel. Median 510(k) review time: 102 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 |
|---|---|---|---|
| HGX | Pump, Breast, Powered | 4 | 4 |
| HGY | Pump, Breast, Non-Powered | 1 | 1 |
Review panels
Most recent Crystal Medical Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K861513 | LA DIFFUSION TECHNIQUE, KTY CM-10 BREAST PUMP | HGX | 1986-08-08 | 107 |
| K853107 | AXICARE CM-14 AUTOMATIC BREAST PUMP | HGX | 1985-11-19 | 119 |
| K850753 | NATURAL MOTHER BREAST PUMP | HGX | 1985-06-07 | 102 |
| K850242 | CRYSTAL MANUAL BREAST PUMP | HGY | 1985-02-25 | 34 |
| K842766 | CRYSTAL MEDICAL MILK COLLECTION KIT | HGX | 1984-09-25 | 71 |
Recalls
openFDA lists no recalls under a recalling firm named Crystal Medical 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 Crystal Medical Products, Inc. have?
Crystal Medical Products, Inc. has 5 FDA 510(k) clearances (first 1984, latest 1986), across 2 product codes in 1 review panel.
How long does FDA take to clear Crystal Medical Products, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Crystal Medical Products, Inc.'s cleared 510(k)s is 102 days.
What devices does Crystal Medical Products, Inc. make?
Its most frequent FDA product codes are HGX (Pump, Breast, Powered, 4); HGY (Pump, Breast, Non-Powered, 1).
Has Crystal Medical Products, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Crystal Medical Products, Inc. Related entities may recall under other names.
Next steps
- See all 5 Crystal Medical Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HGX, Crystal Medical 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.