510(k) · Cleared
ClearedSwabsite Swabbable Valve, Model 245000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quest Medical, Inc. · FPA Set, Administration, Intravascular
Cleared on Mar 6, 2001 as substantially equivalent to K970485 (Ivac Medical Systems, 1997) after a 189-day review. Its family tree reaches back 2 generations to 1990. 3 later devices descend from it.
- Decided
- Mar 6, 2001
- Review
- 189 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K901063 (1990). 4 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK901063 Luer Lock Transfer PinAcacia, Inc. · 1990
- 1 generation backK970485 Smartsite Access PinIvac Medical Systems · 1997 · Recalled
- This deviceK002689 Swabsite Swabbable Valve, Model 245000Quest Medical, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK120548 Hlic Needle-Less ValveHealth Line International Corporation · 2012
- Descendant · cites it directly · 0 of its ownK112073 Infusite Needleless Acces Device (Sterile, Bulk Non-Sterile) and…Rx Devices, LLC · 2012
- Descendant · cites it directly · 0 of its ownK061143 Robertsite StopcockHalkey-Roberts Corp. · 2006
Most influential descendants
Showing 3 of 3 · See all- K120548Hlic Needle-Less ValveHealth Line International Corporation · 2012 · cites it directly0descendants
- K112073Infusite Needleless Acces Device (Sterile, Bulk Non-Sterile) and Infusite Needleless…Rx Devices, LLC · 2012 · cites it directly0descendants
- K061143Robertsite StopcockHalkey-Roberts Corp. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K901063 | Luer Lock Transfer Pin | Acacia, Inc. | 1990 | — |
| −1 | K970485 | Smartsite Access Pin | Ivac Medical Systems | 1997 | 3 |
| 0 (this device) | K002689 | Swabsite Swabbable Valve, Model 245000 | Quest Medical, Inc. | 2001 | — |
| +1 | K120548 | Hlic Needle-Less Valve | Health Line International Corporation | 2012 | — |
| +1 | K112073 | Infusite Needleless Acces Device (Sterile, Bulk Non-Sterile) and Infusite… | Rx Devices, LLC | 2012 | — |
| +1 | K061143 | Robertsite Stopcock | Halkey-Roberts Corp. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2012 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FPA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K970485 | Smartsite Access PinSummary page 1…prietary Name: Swabsite Swabbable Valve Intravascular Administration Set Swabbable Valve intravascular Administration Set .V. Fluid Transfer Set Smartsite Access Pin, K970485 The Swabsite Swabbable Valve is a needle free valve that allows the user to add medication into IV sets without the use of a nee… | 1997 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 6.8 years on median.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K120548 (Health Line International Corporation, 2012) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K970485.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, 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 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
The SWABSITE injection port is an IV administration set accessory that allows needleless luer connections to luer access devices (syringes, etc.)
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K002689 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002689: Swabsite Swabbable Valve, Model 245000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K002689
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026