Dayspring Medical, Inc.: FDA clearances and approvals
Dayspring Medical, Inc. has 5 FDA 510(k) clearances (first 1996, latest 1999), across 3 product codes in 1 review panel. Median 510(k) review time: 89 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 |
|---|---|---|---|
| FJI | Dialyzer, Capillary, Hollow Fiber | 3 | 3 |
| FKY | Connector, Tubing, Dialysate | 1 | 1 |
| LLB | System, Blood, Extracorporeal And Accessories | 1 | 1 |
Review panels
Most recent Dayspring Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K991005 | VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING MEDICAL PART NO, DPC101VS | LLB | 1999-06-22 | 89 |
| K991003 | PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT RINSE LINE W/ LUER-LOCK CONNECTOR, T-CONNECTOR, SHORT, W/ SLI | FKY | 1999-06-09 | 76 |
| K961039 | BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CAP WITH RED PLIABLE VINYL | FJI | 1996-09-12 | 182 |
| K961040 | BLOOD PORT CAP, DIALYSATE PORT CAP, RED HARD PLASTIC | FJI | 1996-06-11 | 89 |
| K961026 | BLOOD PORT CAP, LUER-LOCK FITTING, DAYSPRING MEDICAL PART NO. BPC252LL | FJI | 1996-06-10 | 88 |
Recalls
openFDA lists no recalls under a recalling firm named Dayspring Medical, 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 Dayspring Medical, Inc. have?
Dayspring Medical, Inc. has 5 FDA 510(k) clearances (first 1996, latest 1999), across 3 product codes in 1 review panel.
How long does FDA take to clear Dayspring Medical, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Dayspring Medical, Inc.'s cleared 510(k)s is 89 days.
What devices does Dayspring Medical, Inc. make?
Its most frequent FDA product codes are FJI (Dialyzer, Capillary, Hollow Fiber, 3); FKY (Connector, Tubing, Dialysate, 1); LLB (System, Blood, Extracorporeal And Accessories, 1).
Has Dayspring Medical, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Dayspring Medical, Inc. Related entities may recall under other names.
Next steps
- See all 5 Dayspring Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FJI, Dayspring Medical, 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.