Crosstex International: FDA clearances and approvals
Crosstex International has 6 FDA 510(k) clearances (first 2008, latest 2014), across 3 product codes in 1 review panel. Median 510(k) review time: 148 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 3 | 200 |
| 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 |
|---|---|---|---|
| FXX | Mask, Surgical | 3 | 3 |
| JOJ | Indicator, Physical/Chemical Sterilization Process | 2 | 2 |
| FRC | Indicator, Biological Sterilization Process | 1 | 1 |
Review panels
- General Hospital (6)
Most recent Crosstex International 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K140566 | SPSMEDICAL VH2O2 INDICATOR STRIPS, INDICATOR LABELS, INDICATOR TAPE | JOJ | 2014-11-24 | 264 |
| K140620 | SPORVIEW PLUS BI TEST PACK | FRC | 2014-08-07 | 149 |
| K133204 | AIRVIEW MINI OWIE DICK TEST PACK | JOJ | 2014-05-05 | 200 |
| K111343 | CROSSTEX ISOFLUID PLUS SURGICAL EARLOOP MASK-BLUE, CROSSTEX ISOFLUID PLUS FOGFREE SURGICAL EARLOOP FACE MASK-BLUE, CROSS | FXX | 2011-10-06 | 146 |
| K103303 | CROSSTEX SURGICAL EARLOOP MASK- WHITE, CROSSTEX SURGICAL EARLOOP NO FOG MASK-WHITE, NO FOG MASK WITH SPLASH VISOR-WHITE | FXX | 2010-12-23 | 44 |
| K082258 | CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR | FXX | 2008-10-16 | 69 |
Recalls
openFDA lists no recalls under a recalling firm named Crosstex International.
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 Crosstex International have?
Crosstex International has 6 FDA 510(k) clearances (first 2008, latest 2014), across 3 product codes in 1 review panel.
How long does FDA take to clear Crosstex International's 510(k)s?
The median time from FDA receipt to decision across Crosstex International's cleared 510(k)s is 148 days.
What devices does Crosstex International make?
Its most frequent FDA product codes are FXX (Mask, Surgical, 3); JOJ (Indicator, Physical/Chemical Sterilization Process, 2); FRC (Indicator, Biological Sterilization Process, 1).
Has Crosstex International had device recalls?
openFDA lists no recalls under a recalling firm name matching Crosstex International. Related entities may recall under other names.
Next steps
- See all 6 Crosstex International clearances with predicates and recalls
- Run predicate analysis for product code FXX, Crosstex International'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.