510(k) · Cleared
Recalled · 2010Millennium Huber Plus Safety Infusion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Millennium Medical Distribution, Inc. · FPA Set, Administration, Intravascular
Cleared on Jan 27, 2000 as substantially equivalent to K890127 (Multi-Med, Inc., 1989) and 4 other predicates after a 76-day review. Its family tree reaches back 1 generation to 1989. 80 later devices descend from it. It has been recalled 2 times.
- Decided
- Jan 27, 2000
- Review
- 76 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 2
- Predicates
- 5
Its longest line of descent runs back 1 generation to K890127 (1989). 5 ancestors in all. 80 later devices descend from it, 7 citing it directly.
- Root · 1 generation backK890127 Intravascular Administration SetMulti-Med, Inc. · 1989
- This deviceK993848 Millennium Huber Plus Safety Infusion SetMillennium Medical Distribution, Inc. · 2000
- Descendant · cites it directly · 70 of its ownK013394 Liftloc Safety Infusion SetSpecialized Health Products, Inc. · 2001 · Recalled
- Descendant · 2 generations on · 68 of its ownK042234 Modification to: Liftloc Saftey Infusion SetSpecialty Health Products, Inc. · 2004
- Descendant · 2 generations on · 67 of its ownK050600 Miniloc Safety Infusion SetSpecialized Health Products, Intl. · 2005 · Recalled
- Descendant · 3 generations on · 66 of its ownK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
- Descendant · cites it directly · 24 of its ownK013871 Lifeguard Safety Infusion SetHorizon Medical Products, Inc. · 2002 · Recalled
Showing 5 of 80 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 80 · See all- K013394Liftloc Safety Infusion SetSpecialized Health Products, Inc. · 2001 · cites it directly70descendants
- K042234Modification to: Liftloc Saftey Infusion SetSpecialty Health Products, Inc. · 2004 · 2 generations on68descendants
- K050600Miniloc Safety Infusion SetSpecialized Health Products, Intl. · 2005 · 2 generations on67descendants
- K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc. · 2006 · 3 generations on66descendants
- K013871Lifeguard Safety Infusion SetHorizon Medical Products, Inc. · 2002 · cites it directly24descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K890127 | Intravascular Administration Set | Multi-Med, Inc. | 1989 | — |
| 0 (this device) | K993848 | Millennium Huber Plus Safety Infusion Set | Millennium Medical Distribution, Inc. | 2000 | — |
| +1 | K013394 | Liftloc Safety Infusion Set | Specialized Health Products, Inc. | 2001 | 1 |
| +2 | K042234 | Modification to: Liftloc Saftey Infusion Set | Specialty Health Products, Inc. | 2004 | — |
| +2 | K050600 | Miniloc Safety Infusion Set | Specialized Health Products, Intl. | 2005 | 2 |
| +3 | K060812 | Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple | C.R. Bard, Inc. | 2006 | 1 |
| +1 | K013871 | Lifeguard Safety Infusion Set | Horizon Medical Products, Inc. | 2002 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 3 | 0 |
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 11 | 0 |
| 2008 | 7 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K890127 | Intravascular Administration SetSummary page 1…Regulation Number 21 CFR 880.5440 Identification of Predicate Devices e ALL-MED Non-Coring Needle Winged Administration Set, Multi-Med Corporation, West Swanzey, NH; K890127, K890340, K891072, K891919. ® Angel Wing Safety Blood Collection and Infusion Set, MBO Laboratories, Inc., Lowell, MA (now owned… | 1989 |
| * | K890340 | Intravascular Administration SetSummary page 1…ion Number 21 CFR 880.5440 Identification of Predicate Devices e ALL-MED Non-Coring Needle Winged Administration Set, Multi-Med Corporation, West Swanzey, NH; K890127, K890340, K891072, K891919. ® Angel Wing Safety Blood Collection and Infusion Set, MBO Laboratories, Inc., Lowell, MA (now owned by Kenda… | 1989 |
| * | K891072 | Intravascular Administration SetSummary page 1…r 21 CFR 880.5440 Identification of Predicate Devices e ALL-MED Non-Coring Needle Winged Administration Set, Multi-Med Corporation, West Swanzey, NH; K890127, K890340, K891072, K891919. ® Angel Wing Safety Blood Collection and Infusion Set, MBO Laboratories, Inc., Lowell, MA (now owned by Kendall TYCO/S… | 1989 |
| * | K891919 | Intravascular Administration SetSummary page 1…880.5440 Identification of Predicate Devices e ALL-MED Non-Coring Needle Winged Administration Set, Multi-Med Corporation, West Swanzey, NH; K890127, K890340, K891072, K891919. ® Angel Wing Safety Blood Collection and Infusion Set, MBO Laboratories, Inc., Lowell, MA (now owned by Kendall TYCO/Sherwood D… | 1989 |
| * | K912563 | Angel Wing Safety Blood Collection and Infusion SESummary page 1…890340, K891072, K891919. ® Angel Wing Safety Blood Collection and Infusion Set, MBO Laboratories, Inc., Lowell, MA (now owned by Kendall TYCO/Sherwood Davis and Geck), K912563 Device Description: The Millennium Huber Plus Safety Infusion Set is a standard non-coring right angle Huber needle and adminis… | 1991 |
What descends from it? (80)
See all 807 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013394 | Liftloc Safety Infusion Set | 2001 | 70 |
| K013871 | Lifeguard Safety Infusion Set | 2002 | 24 |
| K021565 | Luther Safety Huber Needle Set | 2002 | 17 |
| K051009 | Huber Clear Safety Infusion Set | 2005 | 5 |
| K032934 | MPS Acacia Safeguard Huber Device | 2003 | 3 |
| K170881 | ISP Safety Huber Needle Infusion Set | 2017 | 0 |
| K021488 | Surecan Safety Huber Needle Infusion Sets | 2002 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 14, 2010 | Not classified | Z-0861-2010 | Component change control | After activation of the safety mechanism, the tip of the needle protrudes from the safety sheath creating the potential for needlestick injury. |
| Jan 14, 2010 | Not classified | Z-0862-2010 | Component change control | After activation of the safety mechanism, the tip of the needle protrudes from the safety sheath creating the potential for needlestick injury. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K013394 (Specialized Health Products, Inc., 2001) has gone furthest, with 70 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 Millennium Huber Plus Safety Infusion Set is a safety IV administration set with a non-coring, ninety-degree, right-angle Huber needle, used to access surgically implanted vascular ports. The Huber needle is used to administer fluids or to withdraw blood. The Huber Plus system facilitates safe removal of the needle by encapsulating the needle within the attachment wings to help prevent needlestick injuries when using the device for vascular port access.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993848 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993848: Millennium Huber Plus Safety 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/K993848
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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