510(k) · Cleared
ClearedHuber Clear Safety Infusion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Now Medical Distribution, Inc. · FPA Set, Administration, Intravascular
Cleared on Jul 12, 2005 as substantially equivalent to K993848 (Millennium Medical Distribution, Inc., 2000) after an 82-day review. Its family tree reaches back 2 generations to 1989. 5 later devices descend from it.
- Decided
- Jul 12, 2005
- Review
- 82 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K890127 (1989). 6 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK890127 Intravascular Administration SetMulti-Med, Inc. · 1989
- 1 generation backK993848 Millennium Huber Plus Safety Infusion SetMillennium Medical Distribution, Inc. · 2000 · Recalled
- This deviceK051009 Huber Clear Safety Infusion SetNow Medical Distribution, Inc. · 2005
- Descendant · cites it directly · 4 of its ownK082306 Powerloc Clear Safety Infusion SetC.R. Bard, Inc. · 2008
- Descendant · 2 generations on · 2 of its ownK111101 Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011
- Descendant · 3 generations on · 1 of its ownK112713 Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc. · 2011
- Descendant · 4 generations on · 0 of its ownK192291 TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK120261 PPS PI Pressure Injectable Safety Huber Needle Without Lateral…Perouse Medical · 2012
Most influential descendants
Showing 5 of 5 · See all- K082306Powerloc Clear Safety Infusion SetC.R. Bard, Inc. · 2008 · cites it directly4descendants
- K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011 · 2 generations on2descendants
- K112713Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc. · 2011 · 3 generations on1descendant
- K192291TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc. · 2020 · 4 generations on0descendants
- K120261PPS PI Pressure Injectable Safety Huber Needle Without Lateral Injection Site, PPS PI…Perouse Medical · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K890127 | Intravascular Administration Set | Multi-Med, Inc. | 1989 | — |
| −1 | K993848 | Millennium Huber Plus Safety Infusion Set | Millennium Medical Distribution, Inc. | 2000 | 2 |
| 0 (this device) | K051009 | Huber Clear Safety Infusion Set | Now Medical Distribution, Inc. | 2005 | — |
| +1 | K082306 | Powerloc Clear Safety Infusion Set | C.R. Bard, Inc. | 2008 | — |
| +2 | K111101 | Norport CT-PC, Lucent Non-Coring Needel Infusion Set | Norfolk Medical | 2011 | — |
| +3 | K112713 | Norfolk Medical-Sportport-Family of Ports | Norfolk Medical Products, Inc. | 2011 | — |
| +4 | K192291 | TidalPort-AP Implantable Apheresis Vascular Access Port | Norfolk Medical Products, Inc. | 2020 | — |
| +2 | K120261 | PPS PI Pressure Injectable Safety Huber Needle Without Lateral Injection Site… | Perouse Medical | 2012 | — |
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 |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2020 | 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? (1)
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 |
|---|---|---|---|
| * | K993848 | Millennium Huber Plus Safety Infusion SetSummary page 1…Regulation Number 21 CFR 880.5440 Identification of Predicate Devices * NOW Huber Plus Safety Infusion Set, NOW Medical Distribution, Chadds Ford, PA K993848 Device Description: The NOW Huber ClearTM Safety Infusion Set is a standard non-coring right angle Huber needle and administrat… | 2000 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082306 | Powerloc Clear Safety Infusion Set | 2008 | 4 |
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 16 years and passes through 3 companies; a new generation was cleared every 11.0 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K082306 (C.R. Bard, Inc., 2008) has gone furthest, with 4 descendants of its own.
- 6 other devices also cite its predicate K993848.
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 NOW Huber Clear TM 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 Clear TM 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 as stated in the FDA summary.
https://510kreport.com/device/K051009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051009: Huber Clear 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/K051009
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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