510(k) · Cleared
ClearedUnassigned
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcomp · FPA Set, Administration, Intravascular
Cleared on Aug 14, 2008 as substantially equivalent to K071846 (Pfm Medical, Inc., 2007) after a 169-day review. Its family tree reaches back 8 generations to 2000. 6 later devices descend from it.
- Decided
- Aug 14, 2008
- Review
- 169 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K001901 (2000). 23 ancestors in all, the oldest K863606 (1986). 6 later devices descend from it, 2 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 backK071846 Modification to EZ Huber Safety Infusion SetPfm Medical, Inc. · 2007
- This deviceK080544 UnassignedMedcomp · 2008
- Descendant · cites it directly · 2 of its ownK132880 Medcomp Power Injectable Safety Huber NeedleMedical Components, Inc. · 2014
- Descendant · cites it directly · 2 of its ownK111101 Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011
- Descendant · 2 generations on · 1 of its ownK162271 Pro-Lock CT Safety Infusion SetMedcomp (Medical Components, Inc.) · 2017
- Descendant · 2 generations on · 1 of its ownK112713 Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc. · 2011
- Descendant · 3 generations on · 0 of its ownK192291 TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K132880Medcomp Power Injectable Safety Huber NeedleMedical Components, Inc. · 2014 · cites it directly2descendants
- K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011 · cites it directly2descendants
- K162271Pro-Lock CT Safety Infusion SetMedcomp (Medical Components, Inc.) · 2017 · 2 generations on1descendant
- K112713Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc. · 2011 · 2 generations on1descendant
- K192291TidalPort-AP Implantable Apheresis Vascular Access PortNorfolk Medical Products, Inc. · 2020 · 3 generations on0descendants
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 | K071846 | Modification to EZ Huber Safety Infusion Set | Pfm Medical, Inc. | 2007 | — |
| 0 (this device) | K080544 | Unassigned | Medcomp | 2008 | — |
| +1 | K132880 | Medcomp Power Injectable Safety Huber Needle | Medical Components, Inc. | 2014 | — |
| +1 | K111101 | Norport CT-PC, Lucent Non-Coring Needel Infusion Set | Norfolk Medical | 2011 | — |
| +2 | K162271 | Pro-Lock CT Safety Infusion Set | Medcomp (Medical Components, Inc.) | 2017 | — |
| +2 | K112713 | Norfolk Medical-Sportport-Family of Ports | Norfolk Medical Products, Inc. | 2011 | — |
| +3 | K192291 | TidalPort-AP Implantable Apheresis Vascular Access Port | Norfolk Medical Products, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1989 | 4 | 0 |
| 1991 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 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 |
|---|---|---|---|
| * | K071846 | Modification to EZ Huber Safety Infusion SetSummary page 1…FPA C.F.R. Section: 880.5440 Class: II C. Predicate Device: K071846, EZ Huber Safety Infusion Set, PFM Medical, Inc. D. Device Description:… | 2007 |
What descends from it? (6)
2 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)
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 8 years and passes through 4 companies; a new generation was cleared every 12 months on median.
- 11 of the 23 ancestors have a recall of any class.
- Of its descendants, K132880 (Medical Components, Inc., 2014) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K071846.
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 CT Injectable Safety Huber Needle is a device used to administer fluids from a container to a patient's vascular system through an implanted port. The CT Injectable Safety Huber Needle incorporates an active safety feature that aids in the prevention of accidental needle sticks.
The CT Injectable Safety Huber Needle is a safety needle designed with an anti-coring needle tip configuration. The primary use for Huber Needles is to deliver solutions to implanted ports. The safety feature is designed to protect the practitioner from accidental needle sticks.
The CT Injectable Safety Huber Needle is compatible with power injection procedures up to 300 psi.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080544 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080544: Unassigned.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080544
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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