510(k) · Cleared
ClearedMPS Acacia Safeguard Huber Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mps Acacia · FPA Set, Administration, Intravascular
Cleared on Nov 13, 2003 as substantially equivalent to K982047 (Medical Product Specialists, 1998) and 3 other predicates after a 52-day review. Its family tree reaches back 3 generations to 1989. 3 later devices descend from it.
- Decided
- Nov 13, 2003
- Review
- 52 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K890127 (1989). 10 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK890127 Intravascular Administration SetMulti-Med, Inc. · 1989
- 2 generations backK993848 Millennium Huber Plus Safety Infusion SetMillennium Medical Distribution, Inc. · 2000 · Recalled
- 1 generation backK013871 Lifeguard Safety Infusion SetHorizon Medical Products, Inc. · 2002 · Recalled
- This deviceK032934 MPS Acacia Safeguard Huber DeviceMps Acacia · 2003
- Descendant · cites it directly · 2 of its ownK090809 MPS Acacia Power Injectable Infusion SetMps Acacia · 2009
- Descendant · 2 generations on · 1 of its ownK142527 Extension Set with BD Q-Syte Luer Access Split SeptumAcacia, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK202672 Precision Delivery Infusion SetQuest Medical, Inc. · 2021 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K090809MPS Acacia Power Injectable Infusion SetMps Acacia · 2009 · cites it directly2descendants
- K142527Extension Set with BD Q-Syte Luer Access Split SeptumAcacia, Inc. · 2014 · 2 generations on1descendant
- K202672Precision Delivery Infusion SetQuest Medical, Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K890127 | Intravascular Administration Set | Multi-Med, Inc. | 1989 | — |
| −2 | K993848 | Millennium Huber Plus Safety Infusion Set | Millennium Medical Distribution, Inc. | 2000 | 2 |
| −1 | K013871 | Lifeguard Safety Infusion Set | Horizon Medical Products, Inc. | 2002 | 3 |
| 0 (this device) | K032934 | MPS Acacia Safeguard Huber Device | Mps Acacia | 2003 | — |
| +1 | K090809 | MPS Acacia Power Injectable Infusion Set | Mps Acacia | 2009 | — |
| +2 | K142527 | Extension Set with BD Q-Syte Luer Access Split Septum | Acacia, Inc. | 2014 | — |
| +3 | K202672 | Precision Delivery Infusion Set | Quest Medical, Inc. | 2021 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K982047 | MPS Huber Needle Extension SetSummary page 1…Device Common name: Set, Administration, Intravascular Predicate device: MPS Acacia Huber Needle Extension Set 510(k) number: K982047 Marketed by: MPS Acacia 499 Nibus St., Suite E Brea, CA… | 1998 |
| * | K993848 | Millennium Huber Plus Safety Infusion SetSummary page 1…499 Nibus St., Suite E Brea, CA 92821 Predicate device: Millennium Huber Plus Safety Infusion Set 510(k) number: K993848 Marketed by: Millennium Medical (Aka Now Medical) 696 Unionville Road, Suite 6… | 2000 |
| * | K021565 | Luther Safety Huber Needle Set | 2002 |
| * | K013871 | Lifeguard Safety Infusion Set | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090809 | MPS Acacia Power Injectable Infusion Set | 2009 | 2 |
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 14 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 10 ancestors have a recall of any class.
- Of its descendants, K090809 (Mps Acacia, 2009) has gone furthest, with 2 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?
The MPS Acacia Safeguard Huber Device is intended: a) for use with implanted infusion ports for continuous or intermittent infusion therapy; and b) for infusion or withdrawal of I.V. fluids, blood, blood products, and drugs. The MPS Acacia Safeguard Huber Device should be changed per CDC guidelines or per hospital protocol.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032934 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032934: MPS Acacia Safeguard Huber Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032934
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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