Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dayspring Medical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
89 daysmedian FDA review time
182 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K991005 | VENTED DIAKYSATE PORT CCAP, RED PLIABLE VINYL - DAYSPRING ME | Dayspring Medical, Inc. | 1999-06-22 | 89 | 0 |
| K991003 | PUMP SEGMENT RINSE LINE W/ SLIP-ON CONNECTOR, PUMP SEGMENT R | Dayspring Medical, Inc. | 1999-06-09 | 76 | 0 |
| K961039 | BLLOD PORT CAP, DIALYSATE PORT CAP, VENTED DIALYSATE PORT CA | Dayspring Medical, Inc. | 1996-09-12 | 182 | 0 |
| K961040 | BLOOD PORT CAP, DIALYSATE PORT CAP, RED HARD PLASTIC | Dayspring Medical, Inc. | 1996-06-11 | 89 | 0 |
| K961026 | BLOOD PORT CAP, LUER-LOCK FITTING, DAYSPRING MEDICAL PART NO | Dayspring Medical, Inc. | 1996-06-10 | 88 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda