510(k) · Cleared
ClearedMPS Acacia Power Injectable Infusion Set
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 Apr 28, 2009 as substantially equivalent to K032934 (Mps Acacia, 2003) and 2 other predicates after a 34-day review. Its family tree reaches back 9 generations to 2000. 2 later devices descend from it.
- Decided
- Apr 28, 2009
- Review
- 34 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K001901 (2000). 39 ancestors in all, the oldest K863606 (1986). 2 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 5 generations between
- 3 generations backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
- 2 generations backK062414 Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · Recalled
- 1 generation backK073050 Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · Recalled
- This deviceK090809 MPS Acacia Power Injectable Infusion SetMps Acacia · 2009
- Descendant · cites it directly · 1 of its ownK142527 Extension Set with BD Q-Syte Luer Access Split SeptumAcacia, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK202672 Precision Delivery Infusion SetQuest Medical, Inc. · 2021 · Recalled
Show all 9 generations
- Root · 9 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 8 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 7 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 6 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 5 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- 4 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- 3 generations backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
- 2 generations backK062414 Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · Recalled
- 1 generation backK073050 Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · Recalled
- This deviceK090809 MPS Acacia Power Injectable Infusion SetMps Acacia · 2009
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −8 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −7 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −6 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −5 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| −4 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| −3 | K060812 | Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple | C.R. Bard, Inc. | 2006 | 1 |
| −2 | K062414 | Vortex CT Port Access System and Lifeguard Safety Infusion Set | Rita Medical Systems, Inc. | 2007 | 2 |
| −1 | K073050 | Safestep Max Power-Injectable Infusion Set | Specialized Health Products International, Inc. | 2008 | 2 |
| 0 (this device) | K090809 | MPS Acacia Power Injectable Infusion Set | Mps Acacia | 2009 | — |
| +1 | K142527 | Extension Set with BD Q-Syte Luer Access Split Septum | Acacia, Inc. | 2014 | — |
| +2 | K202672 | Precision Delivery Infusion Set | Quest Medical, Inc. | 2021 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 4 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 3 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K032934 | MPS Acacia Safeguard Huber DeviceSummary page 1…travascular Administration Set DEVICE CLASSIFICATION: Class II PRODUCT CODE FPA PREDICATE DEVICES: MPS Acacia Safeguard Huber Device (K032934) SafeStep Max Power Injectable Infusion Set (K073050) Medegen Pressur… | 2003 |
| * | K073050 | Safestep Max Power-Injectable Infusion SetSummary page 1…CODE FPA PREDICATE DEVICES: MPS Acacia Safeguard Huber Device (K032934) SafeStep Max Power Injectable Infusion Set (K073050) Medegen Pressure Rated Extension Set (K083472) Substantially Equivalent To: The MPS Acacia Powe… | 2008 |
| * | K083472 | Medegen Pressure Rated Extension SetsSummary page 1…r Device (K032934) SafeStep Max Power Injectable Infusion Set (K073050) Medegen Pressure Rated Extension Set (K083472) Substantially Equivalent To: The MPS Acacia Power Injectable Infusion Set is substantially equivalent in intended use, princi… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142527 | Extension Set with BD Q-Syte Luer Access Split Septum | 2014 | 1 |
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 9 years and passes through 5 companies; a new generation was cleared every 12 months on median.
- 22 of the 39 ancestors have a recall of any class.
- Of its descendants, K142527 (Acacia, Inc., 2014) 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. 2009, this device’s year, is highlighted.
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 Power Injectable Infusion Set with Huber Needle is indicated for: Use with implanted infusion ports for continuous or intermittent infusion therapy. Infusion or withdrawal of IVfluids, blood, blood products, or drugs. Use with ports that are indicated for power injection of contrast media into the central venous system. For power injection of contrast media, the maximum recommended infusion rate is 5mL/sec. for 19 gauge and 20 gauge needles, and…
Read the full statement (145 words)
The Power Injectable Infusion Set with Huber Needle is indicated for:
Use with implanted infusion ports for continuous or intermittent infusion therapy.
Infusion or withdrawal of IVfluids, blood, blood products, or drugs.
Use with ports that are indicated for power injection of contrast media into the central venous system. For power injection of contrast media, the maximum recommended infusion rate is 5mL/sec. for 19 gauge and 20 gauge needles, and 2mL/sec. for 22 gauge needles.
Power injection of contrast media up to 325 PSI.
The Power Injectable Infusion Set with male luer lock is indicated for:
Use with central venous catheters for continuous or intermittent infusion therapy.
Infusion or withdrawal of IVfluids, blood, blood products, or drugs.
Use with central venous catheters that are indicated for power injection of contrast media into the central venous system.
Power injection of contrast media up to 325 PSI.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090809 · printed Nov 3, 2026
Cite this page
510(k) Report. “K090809: MPS Acacia Power Injectable Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K090809
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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