Crossbay Medical: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Crossbay Medical” (first 2014, latest 2020), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 158 days. Since 2017 the median was 155 days, against 190 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2014 | 1 | 153 |
| 2015 | 1 | 191 |
| 2016 | 0 | — |
| 2017 | 1 | 163 |
| 2018 | 0 | — |
| 2019 | 1 | 147 |
| 2020 | 2 | 106 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Crossbay Medical took a median 155 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 190 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HHK | Curette, Suction, Endometrial (And Accessories) | 2 | 2 |
| LKF | Cannula, Manipulator/Injector, Uterine | 1 | 1 |
| MQF | Catheter, Assisted Reproduction | 1 | 1 |
| PGK | Cannula, Injector, Uterine, Endometrial Biopsy | 1 | 1 |
| PON | Catheter, Balloon, Dilation Of Cervical Canal | 1 | 1 |
Review panels
Most recent Crossbay Medical 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K201952 | CrossGlide ETS Plus | HHK | 2020-08-05 | 22 |
| K192534 | CrossBay Endometrial Tissue Sampler (ETS) | HHK | 2020-03-25 | 191 |
| K190813 | CrossBay Cervical Dilator Catheter System | PON | 2019-08-23 | 147 |
| K162064 | CrossBay IVF Embryo Transfer Catheter Set | MQF | 2017-01-05 | 163 |
| K142545 | SonoFlow Sonohysterography and Sonohysterosalpingography Device | LKF | 2015-03-20 | 191 |
| K133144 | SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE | PGK | 2014-03-19 | 153 |
Recalls
openFDA lists no recalls under a recalling firm named Crossbay Medical.
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 Crossbay Medical?
FDA lists 6 510(k) clearances under the applicant name “Crossbay Medical” (first 2014, latest 2020), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Crossbay Medical?
The median time from FDA receipt to decision across 510(k)s cleared under the name Crossbay Medical is 158 days. Since 2017: 155 days, versus 190 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Crossbay Medical?
The most frequent FDA product codes under this applicant name are HHK (Curette, Suction, Endometrial (And Accessories), 2); LKF (Cannula, Manipulator/Injector, Uterine, 1); MQF (Catheter, Assisted Reproduction, 1).
Next steps
- See all 6 Crossbay Medical clearances with predicates and recalls
- Run predicate analysis for product code HHK, Crossbay Medical'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.