510(k) · Cleared
Recalled · Class II · 2015Safestep Max Power-Injectable Infusion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Specialized Health Products International, Inc. · FPA Set, Administration, Intravascular
Cleared on Jan 25, 2008 as substantially equivalent to K040527 (Luther Needlesafe Products, Inc., 2004) and 4 other predicates after an 88-day review. Its family tree reaches back 8 generations to 2000. 13 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 25, 2008
- Review
- 88 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 8 generations to K001901 (2000). 35 ancestors in all, the oldest K863606 (1986). 13 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
- 7 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
- 6 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
- 5 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
- 4 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
- 3 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
- 2 generations backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
- 1 generation backK062414 Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · Recalled
- This deviceK073050 Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008
- Descendant · cites it directly · 6 of its ownK170897 Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety…B.Braun Medical, Inc. · 2017
- Descendant · 2 generations on · 2 of its ownK230715 Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2023
- Descendant · 2 generations on · 2 of its ownK200463 Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd · 2021
- Descendant · cites it directly · 2 of its ownK153440 PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetC.R. Bard, Inc. · 2016 · Recalled
- Descendant · cites it directly · 2 of its ownK090809 MPS Acacia Power Injectable Infusion SetMps Acacia · 2009
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with…B.Braun Medical, Inc. · 2017 · cites it directly6descendants
- K230715Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2023 · 2 generations on2descendants
- K200463Huber Needle Infusion Set, Safety Huber Needle Infusion SetJiangsu Caina Medical Co.,Ltd · 2021 · 2 generations on2descendants
- K153440PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle SetC.R. Bard, Inc. · 2016 · cites it directly2descendants
- K090809MPS Acacia Power Injectable Infusion SetMps Acacia · 2009 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K001901 | Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline… | C.R. Bard, Inc. | 2000 | 2 |
| −7 | K012902 | Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath… | C.R. Bard, Inc. | 2001 | — |
| −6 | K031129 | Poly Per-Q-Cath Picc Catheters; Poly Radpicc | C.R. Bard, Inc. | 2003 | — |
| −5 | K034019 | Poly Per-Q-Cath Picc Catheters | C.R. Bard, Inc. | 2004 | 1 |
| −4 | K050931 | 6 FR DL Powerpicc Catheter | C.R. Bard, Inc. | 2005 | — |
| −3 | K051672 | Powerpicc | Bard Access Systems, Inc. | 2005 | 1 |
| −2 | K060812 | Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple | C.R. Bard, Inc. | 2006 | 1 |
| −1 | K062414 | Vortex CT Port Access System and Lifeguard Safety Infusion Set | Rita Medical Systems, Inc. | 2007 | 2 |
| 0 (this device) | K073050 | Safestep Max Power-Injectable Infusion Set | Specialized Health Products International, Inc. | 2008 | — |
| +1 | K170897 | Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle… | B.Braun Medical, Inc. | 2017 | — |
| +2 | K230715 | Promisemed Safety Huber Needle | Promisemed Hangzhou Meditech Co., Ltd. | 2023 | — |
| +2 | K200463 | Huber Needle Infusion Set, Safety Huber Needle Infusion Set | Jiangsu Caina Medical Co.,Ltd | 2021 | — |
| +1 | K153440 | PowerLoc MAX Power Injectable Infusion Set, SafeStep Huber Needle Set | C.R. Bard, Inc. | 2016 | 12 |
| +1 | K090809 | MPS Acacia Power Injectable Infusion Set | Mps Acacia | 2009 | — |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2021 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (5)
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 |
|---|---|---|---|
| * | K040527 | Low Profile Luther Safety HuberSummary page 1…oduct Code: FPA Regulation Number: 21 CFR 880.5440 PREDICATE DEVICES: Trade/Device Name: Luther Sqfety 1-tuber Needle (Re-brandedas "SafStep®Sq/ety HIhber Needle Set ) (K040527, K021565) Regulation Name: Intravascular Administration Set Common/Usual Name: Huber Needle Intravascular Administration Set Regu… | 2004 |
| * | K021565 | Luther Safety Huber Needle SetSummary page 1…e: FPA Regulation Number: 21 CFR 880.5440 PREDICATE DEVICES: Trade/Device Name: Luther Sqfety 1-tuber Needle (Re-brandedas "SafStep®Sq/ety HIhber Needle Set ) (K040527, K021565) Regulation Name: Intravascular Administration Set Common/Usual Name: Huber Needle Intravascular Administration Set Regulation Na… | 2002 |
| * | K060812 | Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleSummary page 3…t changed when compared to the predicate devices. This is the same intended use as the predicates SafeStep ctc Huber Needle Set(K040527), PowerLocTM Safety Infusion Set (K060812). Lifeguard Safety® Safety Infusion Set (K062414) and Gripper Plus : " Power P.A.C. Needle (K070116). The SafeStep® MAXTM Power-… | 2006 |
| * | K062414 | Vortex CT Port Access System and Lifeguard Safety Infusion SetSummary page 3…This is the same intended use as the predicates SafeStep ctc Huber Needle Set(K040527), PowerLocTM Safety Infusion Set (K060812). Lifeguard Safety® Safety Infusion Set (K062414) and Gripper Plus : " Power P.A.C. Needle (K070116). The SafeStep® MAXTM Power-Injectable Infusion Set is intended for use in th… | 2007 |
| * | K070116 | Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power…Summary page 2…tion Set Classification Panel: General Hospital Regulatory Class: II Product Code: FPA Regulation Number: 21 CFR 880.5440 Trade/Device Name: Gripper Plus P.AF. Needle (K070116) Regulation Name: Intravascular Administration Set Commorn/Usual Name: Huber Needle Intravascular Administration Set Regulation N… | 2007 |
What descends from it? (13)
See all 133 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 13, 2015 | Class II | Z-1560-2015 | Labeling False and Misleading | Bard Access Systems is conducting a field action due to the potential that an incorrect Maximum Flow rate label associated to the power injection IFU for the PowerLoc MAX Safety Infusion Set (SWIS) was attached to the outside of the unit… |
| Aug 8, 2014 | Class II | Z-1273-2015 | Nonconforming Material/Component | Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK)… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 20 of the 35 ancestors have a recall of any class.
- Of its descendants, K170897 (B.Braun Medical, Inc., 2017) has gone furthest, with 6 descendants of its own.
- 1 other device also cites its predicate K040527.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 SafeStep® MAXTM Power-Injectable Infusion Set device is an intravascular administration set with a non-coring right angle needle and manually activated needlestick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle. The device is used to access surgically implanted vascular ports. The SafeStep® MAXTM Power-Injectable Infusion Set is indicated for use in the administration of fluids and drugs…
Read the full statement (135 words)
The SafeStep® MAXTM Power-Injectable Infusion Set device is an intravascular administration set with a non-coring right angle needle and manually activated needlestick prevention safety mechanism which reduces the risk of accidental needlestick injuries by shielding the needle. The device is used to access surgically implanted vascular ports.
The SafeStep® MAXTM 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 SafeStep® MAXTM Power-Injectable Infusion Set is also indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/s for 19 gauge and 20 gauge needles, and 2 mi/s for 22 gauge needles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073050 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073050: Safestep Max Power-Injectable Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073050
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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