Hyphen Biomed: FDA clearances and approvals
Hyphen Biomed has 6 FDA 510(k) clearances (first 2005, latest 2007), across 5 product codes in 1 review panel. Median 510(k) review time: 260 days. openFDA lists 5 product recalls by a recalling firm named Hyphen Biomed.
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 |
|---|---|---|---|
| GGN | Plasma, Coagulation Control | 2 | 2 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 1 | 1 |
| JBQ | Antithrombin Iii Quantitation | 1 | 1 |
| KFF | Assay, Heparin | 1 | 1 |
| LCO | Platelet Factor 4 Radioimmunoassay | 1 | 1 |
Review panels
- Hematology (6)
Most recent Hyphen Biomed 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K071255 | ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A | LCO | 2007-09-07 | 126 |
| K050367 | BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6 | KFF | 2006-05-24 | 464 |
| K050365 | BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202 | GGP | 2005-12-27 | 316 |
| K051472 | BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR | GGN | 2005-12-23 | 203 |
| K043007 | BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 | JBQ | 2005-11-07 | 371 |
| K043451 | BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR | GGN | 2005-03-17 | 93 |
Recalls
5 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2018-02-05.
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Hyphen Biomed's product codes (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances does Hyphen Biomed have?
Hyphen Biomed has 6 FDA 510(k) clearances (first 2005, latest 2007), across 5 product codes in 1 review panel.
How long does FDA take to clear Hyphen Biomed's 510(k)s?
The median time from FDA receipt to decision across Hyphen Biomed's cleared 510(k)s is 260 days.
What devices does Hyphen Biomed make?
Its most frequent FDA product codes are GGN (Plasma, Coagulation Control, 2); GGP (Test, Qualitative And Quantitative Factor Deficiency, 1); JBQ (Antithrombin Iii Quantitation, 1).
Has Hyphen Biomed had device recalls?
openFDA lists 5 product recalls in 2 recall events by a recalling firm whose name matches Hyphen Biomed; the most recent began 2018-02-05. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 6 Hyphen Biomed clearances with predicates and recalls
- Run predicate analysis for product code GGN, Hyphen Biomed'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.