510(k) · Cleared
ClearedMPS Huber Needle Extension Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Product Specialists · FPA Set, Administration, Intravascular
Cleared on Jul 21, 1998 after a 41-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.
- Decided
- Jul 21, 1998
- Review
- 41 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK982047 MPS Huber Needle Extension SetMedical Product Specialists · 1998
- Descendant · cites it directly · 3 of its ownK032934 MPS Acacia Safeguard Huber DeviceMps Acacia · 2003
- Descendant · 2 generations on · 2 of its ownK090809 MPS Acacia Power Injectable Infusion SetMps Acacia · 2009
- Descendant · 3 generations on · 1 of its ownK142527 Extension Set with BD Q-Syte Luer Access Split SeptumAcacia, Inc. · 2014
- Descendant · 4 generations on · 0 of its ownK202672 Precision Delivery Infusion SetQuest Medical, Inc. · 2021 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K032934MPS Acacia Safeguard Huber DeviceMps Acacia · 2003 · cites it directly3descendants
- K090809MPS Acacia Power Injectable Infusion SetMps Acacia · 2009 · 2 generations on2descendants
- K142527Extension Set with BD Q-Syte Luer Access Split SeptumAcacia, Inc. · 2014 · 3 generations on1descendant
- K202672Precision Delivery Infusion SetQuest Medical, Inc. · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K982047 | MPS Huber Needle Extension Set | Medical Product Specialists | 1998 | — |
| +1 | K032934 | MPS Acacia Safeguard Huber Device | Mps Acacia | 2003 | — |
| +2 | K090809 | MPS Acacia Power Injectable Infusion Set | Mps Acacia | 2009 | — |
| +3 | K142527 | Extension Set with BD Q-Syte Luer Access Split Septum | Acacia, Inc. | 2014 | — |
| +4 | K202672 | Precision Delivery Infusion Set | Quest Medical, Inc. | 2021 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2021 | 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 |
|---|---|---|---|
| * | — | Gish Vastack® Named without a submission number |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K032934 | MPS Acacia Safeguard Huber Device | 2003 | 3 |
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, K032934 (Mps Acacia, 2003) has gone furthest, with 3 descendants 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?
a. The MPS Huber Needle Extension Set is intended for use with implanted infusion ports for continuous or intermittent infusion therapy.
b. For use for infusion of 1.V. fluids, blood, blood products and drugs.
C. Change per CDC guidelines or per hospital Protocol.
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/K982047 · printed Nov 5, 2026
Cite this page
510(k) Report. “K982047: MPS Huber Needle Extension Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K982047
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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