Dayspring Medical, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Dayspring Medical, Inc.” (first 1996, latest 1999), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 89 days. 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 |
|---|---|---|
| 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 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 Dayspring Medical, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Dayspring Medical, Inc.” (first 1996, latest 1999), across 3 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 Dayspring Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Dayspring Medical, Inc. is 89 days.
Which FDA product codes appear under Dayspring Medical, Inc.?
The most frequent FDA product codes under this applicant name are FJI (Dialyzer, Capillary, Hollow Fiber, 3); FKY (Connector, Tubing, Dialysate, 1); LLB (System, Blood, Extracorporeal And Accessories, 1).
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. 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.