510(k) · Cleared
ClearedHuberpro Safety Huber Infusion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Command Medical Products · FPA Set, Administration, Intravascular
Cleared on Jan 22, 2004 as substantially equivalent to K013871 (Horizon Medical Products, Inc., 2002) and 1 other predicate after a 77-day review. Its family tree reaches back 3 generations to 1989. 1 later device descends from it.
- Decided
- Jan 22, 2004
- Review
- 77 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K890127 (1989). 9 ancestors in all. 1 later device descends 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 deviceK033515 Huberpro Safety Huber Infusion SetCommand Medical Products · 2004
- Descendant · cites it directly · 0 of its ownK083482 Cook Vascular Vital-Ject Power Injectable Safety Infusion SetCook Vascular, Inc. · 2009
Most influential descendants
Showing 1 of 1 · See all- K083482Cook Vascular Vital-Ject Power Injectable Safety Infusion SetCook Vascular, Inc. · 2009 · cites it directly0descendants
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) | K033515 | Huberpro Safety Huber Infusion Set | Command Medical Products | 2004 | — |
| +1 | K083482 | Cook Vascular Vital-Ject Power Injectable Safety Infusion Set | Cook Vascular, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 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 |
|---|---|---|---|
| * | K013871 | Lifeguard Safety Infusion SetSummary page 1…ocesses used to manufacture these solution administration sets are substantially equivalent to like Products currently legally marketed by Horizon Medical Products, Inc. K013871 LifeGuard TM Safety Infusion Set, and Micro Med, Inc. K950597 Core Resistant Huber Infusion Set, The HuberPRO TM Safety Huber Inf… | 2002 |
| * | K950597 | Core-Resistant Huber Infusion Set with Y-SiteSummary page 1…are substantially equivalent to like Products currently legally marketed by Horizon Medical Products, Inc. K013871 LifeGuard TM Safety Infusion Set, and Micro Med, Inc. K950597 Core Resistant Huber Infusion Set, The HuberPRO TM Safety Huber Infusion Sets sets will be packaged in a Tyveklpolyethylene pouch… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083482 | Cook Vascular Vital-Ject Power Injectable Safety Infusion Set | 2009 | 0 |
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 15 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 3 of the 9 ancestors have a recall of any class.
- Of its descendants, K083482 (Cook Vascular, Inc., 2009) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K013871.
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 HuberPRO TM Safety Huber Infusion Set is intended to be used to administer solutions and medications into vascular implant ports. In addition, to minimize the risk of accidental needle stick injury after use, the attached safety guard fully encapulatep the needle when manually activated during withdrawal.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033515 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033515: Huberpro Safety Huber Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033515
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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