510(k) · Cleared
ClearedK-Shield Port Access Infusion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kawasumi Laboratories, Inc. · FPA Set, Administration, Intravascular
Cleared on Jun 6, 2006 after a 92-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Jun 6, 2006
- Review
- 92 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK060580 K-Shield Port Access Infusion SetKawasumi Laboratories, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK123344 K-Shield Advantage Port Access Infusion Set (Pais)Kawasumi Laboratories, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK190233 K-Shield Advantage Port Access Infusion Set (PAIS)Kawasumi Laboratories, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK100720 K-Shield Port Access Infusion Set with High Pressure TubingKawasumi Laboratories, Inc. · 2010 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K123344K-Shield Advantage Port Access Infusion Set (Pais)Kawasumi Laboratories, Inc. · 2013 · cites it directly1descendant
- K190233K-Shield Advantage Port Access Infusion Set (PAIS)Kawasumi Laboratories, Inc. · 2019 · 2 generations on0descendants
- K100720K-Shield Port Access Infusion Set with High Pressure TubingKawasumi Laboratories, Inc. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K060580 | K-Shield Port Access Infusion Set | Kawasumi Laboratories, Inc. | 2006 | — |
| +1 | K123344 | K-Shield Advantage Port Access Infusion Set (Pais) | Kawasumi Laboratories, Inc. | 2013 | — |
| +2 | K190233 | K-Shield Advantage Port Access Infusion Set (PAIS) | Kawasumi Laboratories, Inc. | 2019 | — |
| +1 | K100720 | K-Shield Port Access Infusion Set with High Pressure Tubing | Kawasumi Laboratories, Inc. | 2010 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2019 | 1 | 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 |
|---|---|---|---|
| * | — | Exel Int Secure Touch Safety Huber Infusion Set Named without a submission number |
What descends from it? (3)
2 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?
- Of its descendants, K123344 (Kawasumi Laboratories, Inc., 2013) has gone furthest, with 1 descendant of its own.
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 Port Access Infusion Set with Antineedle Stick Protector is a safety intravascular administration set with a non-coring Huber needle that is used to access an implanted medication port for solution infusion and blood sampling. The port access infusion sets are designed with an integral antineedle stick protector that provides a safety feature intended to minimize accidental needle stick injuries when the needle is activated during removal from the patient's implanted medication port.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060580 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060580: K-Shield Port Access Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060580
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026