510(k) · Cleared
ClearedPump Segment Rinse Line W/ Slip-on Connector, Pump Segment Rinse Line W/ Luer-Lock Connector, T-Connector, Short, W/ Sli
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dayspring Medical, Inc. · FKY Connector, Tubing, Dialysate
Cleared on Jun 9, 1999 after a 76-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Jun 9, 1999
- Review
- 76 days
- Class
- Class II
- Product code
- FKY
- 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 FKY? 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 FKY devicesFKY Connector, Tubing, Dialysate: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FKY
FDA has decided no FKY device since 2007.
Median 510(k) review, days · FKY
Too few FKY 510(k)s in any year since 2007 to give a median.
Recalls per year · FKY
No recall names FKY since 2007.
Adverse event reports per year · FKY
4in 2023
MAUDE reports naming product code FKY, not matched to any one device; reports are not rates.
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 | 2 |
| 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 | — | 0 | 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 | 4 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The rinse lines are used to connect one blood port of a dialyzer to the opposite blood port to create a loop. When both blood ports are so connected, the line itself is connected to a pump on a rinse machine which primes the dialyzer with rinse solution and fills it with a sterilant solution, so the dialyzer can be disinfected, while it is stored on the shelf awaiting its next use. The rinse line is also used for taking a samwple of the sterilant…
Read the full statement (288 words)
The rinse lines are used to connect one blood port of a dialyzer to the opposite blood port to create a loop. When both blood ports are so connected, the line itself is connected to a pump on a rinse machine which primes the dialyzer with rinse solution and fills it with a sterilant solution, so the dialyzer can be disinfected, while it is stored on the shelf awaiting its next use. The rinse line is also used for taking a samwple of the sterilant solution. This is done by inserting a needle through an access site on the rinse line, and taking a sample for testing. The devices are clean, but not sterile.
The t-connectors are used during the rinse procedure of the dialyzer. They connect each end of the two blood ports on a dialyzer to the reprocessing system and allow cleaning solutions to be passed through the membrane of the dialyzer. The devices are clean, but not sterile.
The connecting ends of the rinse lines and the t-connectors are of two possible types: a slip-on connector or a luer-lock, screw-on connector.
The slip-on connector is tapered to securely adhere to the "male" end of the blood port. It is released by pulling it straight off. The surface of the blood port and the surface of the slip-on connector meet, and create a frction seal that prevents any fluids from leaking out of the dialyzer.
The luer-~lock, screw-on connector securely sorews on to the "male’ end of the blood port. It is released by unscrewing it. The surface of the blood port and the surface of the luer-lock, screw-on connector meet, and create a frction seal that prevents any fluids from leaking out of the dialyzer.
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/K991003 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991003: Pump Segment Rinse Line W/ Slip-on Connector, Pump Segment Rinse Line W/ Luer-Lock Connector, T-Connector, Short, W/ Sli.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991003
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026