510(k) · Cleared
Recalled · Class II · 2020PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C.R. Bard, Inc. · FPA Set, Administration, Intravascular
Cleared on Aug 18, 2016 as substantially equivalent to K073050 (Specialized Health Products International, Inc., 2008) and 1 other predicate after a 265-day review. Its family tree reaches back 9 generations to 2000. 2 later devices descend from it. It has been recalled 12 times.
- Decided
- Aug 18, 2016
- Review
- 265 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 12
- Predicates
- 2
Its longest line of descent runs back 9 generations to K001901 (2000). 36 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 deviceK153440 PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetC.R. Bard, Inc. · 2016
- Descendant · cites it directly · 1 of its ownK171735 PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle…C.R. Bard, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK241353 PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle…Bard Access Systems, Inc. · 2024
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 deviceK153440 PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetC.R. Bard, Inc. · 2016
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) | K153440 | PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set | C.R. Bard, Inc. | 2016 | — |
| +1 | K171735 | PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set | C.R. Bard, Inc. | 2017 | — |
| +2 | K241353 | PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set | Bard Access Systems, Inc. | 2024 | — |
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 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K073050 | Safestep Max Power-Injectable Infusion SetSummary page 5…ade Name: SafeStep® MAX Power-Injectable Infusion Set Classification Name: Intravascular Administration Set Premarket Notification:K073050 Manufacturer: Bard Access Systems, Inc. Predicate Devices Trade Name: Luther… | 2008 |
| * | K040527 | Low Profile Luther Safety HuberSummary page 5…Trade Name: Luther Safety Huber Needle Set Classification Name: Intravascular Administration Set Premarket Notification:K040527 Manufacturer: Bard Access Systems, Inc. 20… | 2004 |
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 |
|---|---|---|---|
| K171735 | PowerLoc MAX Power-Injectable Infusion Set and SafeStep Huber Needle Set | 2017 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 19, 2020 | Class II | Z-2666-2020 | Process control | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard… |
| Jun 19, 2020 | Class II | Z-2667-2020 | Process control | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard… |
| Jun 19, 2020 | Class II | Z-2669-2020 | Process control | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard… |
| Jun 19, 2020 | Class II | Z-2664-2020 | Process control | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard… |
| Jun 19, 2020 | Class II | Z-2671-2020 | Process control | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard… |
| Jun 19, 2020 | Class II | Z-2660-2020 | Process control | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard… |
| Jun 19, 2020 | Class II | Z-2662-2020 | Process control | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard… |
| Jun 19, 2020 | Class II | Z-2661-2020 | Process control | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard… |
| Jun 19, 2020 | Class II | Z-2670-2020 | Process control | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard… |
| Jun 19, 2020 | Class II | Z-2665-2020 | Process control | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard… |
| Jun 19, 2020 | Class II | Z-2668-2020 | Process control | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard… |
| Jun 19, 2020 | Class II | Z-2663-2020 | Process control | Potential development of cracks or breaks in the tubing near the Luer or Y site of the device. Devices that have developed breaks or cracks can cause leakage resulting in exposure to chemicals such a chemotherapeutics or biohazard… |
The 5 latest of 12 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 21 of the 36 ancestors have a recall of any class.
- Of its descendants, K171735 (C.R. Bard, Inc., 2017) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K073050.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 PowerLoc MAX® Power-Injectable Infusion Set is an intravascular administration set with a non-coring right angle needle and manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle. The needle is used to access surgically implanted vascular ports. The PowerLoc MAX® Power-Injectable Infusion Set is indicated for use in the administration of fluids and drugs, as well…
Read the full statement (189 words)
The PowerLoc MAX® Power-Injectable Infusion Set is an intravascular administration set with a non-coring right angle needle and manually activated needle stick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle. The needle is used to access surgically implanted vascular ports.
The PowerLoc MAX® Power-Injectable Infusion Set is indicated for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.
When used with ports that are indicated for power injection of contrast media into the central venous system, the PowerLoc MAX® Power-Injectable Infusion Set is also indicated for power injection of contrast media.
For power injection of contrast media, the maximum recommended infusion rate at 11.8 cPs is 5 ml/s for 19 gauge and 20 gauge needles, and 2 ml/s for 22 gauge needles.
The SafeStep® Huber Needle Set is a device intended for insertion into the septum of a subcutaneously implanted port and for the infusion of fluids into the port. The SafeStep® Huber Needle safety feature is manually activated during needle removal, and is designed to aid in the prevention of accidental needlesticks.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153440 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153440: PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153440
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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