510(k) · Cleared
ClearedVented Diakysate Port Ccap, Red Pliable Vinyl - Dayspring Medical Part NO, DPC101VS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dayspring Medical, Inc. · LLB System, Blood, Extracorporeal And Accessories
Cleared on Jun 22, 1999 after an 89-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 22, 1999
- Review
- 89 days
- Class
- Class II
- Product code
- LLB
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All LLB devicesLLB System, Blood, Extracorporeal And Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLB
FDA has decided no LLB device since 2007.
Median 510(k) review, days · LLB
Too few LLB 510(k)s in any year since 2007 to give a median.
Recalls per year · LLB
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLB
No MAUDE report names LLB since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 1 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The devices are used for capping off the two dialysate port access ends of a hollow fiber dialyzer. The devices are used by technicians in a dialysis unit during the cleaning, reprocessing, and disinfecting of the dialyzer. During the disinfecting procedure, the technician fills the dialyzer with a sterilant solution that sterilizes the inner filter membrane of the dialyzer. The dialysate port caps prevent the large-scale leakage of fluid stored inside…
Read the full statement (256 words)
The devices are used for capping off the two dialysate port access ends of a hollow fiber dialyzer. The devices are used by technicians in a dialysis unit during the cleaning, reprocessing, and disinfecting of the dialyzer. During the disinfecting procedure, the technician fills the dialyzer with a sterilant solution that sterilizes the inner filter membrane of the dialyzer. The dialysate port caps prevent the large-scale leakage of fluid stored inside the dialyzer. The vented dialysate port caps, in the process of venting pressure, may leak a very small amount of fluid. The device replaces the original equipment manufacturer's closure ports after the initial use of the dialyzer. The devices are clean, but not sterile.
The inside opening of the caps are tapered to match the standard dialysate ports found on hollow fiber dialyzers. The devices mate directly to the dialysate port. The caps are affixed by placing the open end of the cap over the "male" end of the dialysate ports. They are released by pulling them straight off. The surface of the dialysate port and the surface of the dialysate port cap device meet, and create a friction seal that prevents stored fluids from leaking out of the dialyzer. The vented dialysate port cap has a po-up piece at the top of the device. These vented caps are specifically for use with a sterilant solution known as Renalin, and manufactured by Minntech Corp. This sterilant is known to create pressure inside the dialyzer. The vented cap is a device to relieve this pressure buildup.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K991005 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991005: Vented Diakysate Port Ccap, Red Pliable Vinyl - Dayspring Medical Part NO, DPC101VS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991005
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026