510(k) Report

510(k) · Cleared

Cleared

Modification to EZ Huber Safety Infusion Set

K071846510(k) TraditionalCleared Aug 30, 200756-day reviewClass II21 CFR 880.5440

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Pfm Medical, Inc. · FPA Set, Administration, Intravascular

Cleared on Aug 30, 2007 as substantially equivalent to K040533 (Pfm Medical, Inc., 2004) and 1 other predicate after a 56-day review. Its family tree reaches back 7 generations to 2000. 8 later devices descend from it.

Decided
Aug 30, 2007
Review
56 days
Class
Class II
Product code
FPA
Recalls
None
Predicates
2

Its longest line of descent runs back 7 generations to K001901 (2000). 22 ancestors in all, the oldest K863606 (1986). 8 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 3 other ancestors2005: 2 other ancestors2000: 2 other ancestors2001: 1 other ancestor1987: 1 other ancestor1986: 1 other ancestor1991: 1 other ancestor1989: 4 other ancestors2008: 1 descendant cleared2025: 1 descendant cleared2011: 2 descendants cleared2014: 1 descendant cleared2017: 2 descendants cleared2020: 1 descendant clearedK001901 · Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135 · C.R. Bard, Inc. · 2000 · recalledK012902 · Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100 · C.R. Bard, Inc. · 2001K031129 · Poly Per-Q-Cath Picc Catheters; Poly Radpicc · C.R. Bard, Inc. · 2003K034019 · Poly Per-Q-Cath Picc Catheters · C.R. Bard, Inc. · 2004 · recalledK050931 · 6 FR DL Powerpicc Catheter · C.R. Bard, Inc. · 2005K051672 · Powerpicc · Bard Access Systems, Inc. · 2005 · recalledK060812 · Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple · C.R. Bard, Inc. · 2006 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 3 other ancestors3 generations back: 3 other ancestors4 generations back: 3 other ancestors5 generations back: 5 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 2 descendants K060812 · Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple · C.R. Bard, Inc. · 2006 · recalledK051672 · Powerpicc · Bard Access Systems, Inc. · 2005 · recalledK050931 · 6 FR DL Powerpicc Catheter · C.R. Bard, Inc. · 2005K034019 · Poly Per-Q-Cath Picc Catheters · C.R. Bard, Inc. · 2004 · recalledK031129 · Poly Per-Q-Cath Picc Catheters; Poly Radpicc · C.R. Bard, Inc. · 2003K012902 · Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath Dual Lumen Picc Catheter, Model 3246100 · C.R. Bard, Inc. · 2001K001901 · Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline Catheter, Model 3134135 · C.R. Bard, Inc. · 2000 · recalled−50
  1. Root · 7 generations backK001901 Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath…C.R. Bard, Inc. · 2000 · Recalled
  2. 6 generations backK012902 Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly…C.R. Bard, Inc. · 2001
  3. 5 generations backK031129 Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc. · 2003
  4. 4 generations backK034019 Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc. · 2004 · Recalled
  5. 3 generations backK050931 6 FR DL Powerpicc CatheterC.R. Bard, Inc. · 2005
  6. 2 generations backK051672 PowerpiccBard Access Systems, Inc. · 2005 · Recalled
  7. 1 generation backK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
  8. This deviceK071846 Modification to EZ Huber Safety Infusion SetPfm Medical, Inc. · 2007
  9. Descendant · cites it directly · 6 of its ownK080544 UnassignedMedcomp · 2008
  10. Descendant · 2 generations on · 2 of its ownK132880 Medcomp Power Injectable Safety Huber NeedleMedical Components, Inc. · 2014
  11. Descendant · 2 generations on · 2 of its ownK111101 Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011
  12. Descendant · 3 generations on · 1 of its ownK162271 Pro-Lock CT Safety Infusion SetMedcomp (Medical Components, Inc.) · 2017
  13. Descendant · 3 generations on · 1 of its ownK112713 Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc. · 2011

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2008: 12011: 22014: 12017: 22020: 12025: 1
2008high 2 (2011) · low 0 (2009)2026

Most influential descendants

Showing 5 of 8 · See all
  • K080544UnassignedMedcomp · 2008 · cites it directly6descendants
  • K132880Medcomp Power Injectable Safety Huber NeedleMedical Components, Inc. · 2014 · 2 generations on2descendants
  • K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011 · 2 generations on2descendants
  • K162271Pro-Lock CT Safety Infusion SetMedcomp (Medical Components, Inc.) · 2017 · 3 generations on1descendant
  • K112713Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc. · 2011 · 3 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−7K001901Poly Per-Q-Cath Picc Catheter,Model 3236100 and Poly Per-Q-Cath Midline…C.R. Bard, Inc.20002
−6K012902Poly Per-Q-Cath Single Lumen Picc Catheter, Model 3143100; Poly Per-Q-Cath…C.R. Bard, Inc.2001—
−5K031129Poly Per-Q-Cath Picc Catheters; Poly RadpiccC.R. Bard, Inc.2003—
−4K034019Poly Per-Q-Cath Picc CathetersC.R. Bard, Inc.20041
−3K0509316 FR DL Powerpicc CatheterC.R. Bard, Inc.2005—
−2K051672PowerpiccBard Access Systems, Inc.20051
−1K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc.20061
0 (this device)K071846Modification to EZ Huber Safety Infusion SetPfm Medical, Inc.2007—
+1K080544UnassignedMedcomp2008—
+2K132880Medcomp Power Injectable Safety Huber NeedleMedical Components, Inc.2014—
+2K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical2011—
+3K162271Pro-Lock CT Safety Infusion SetMedcomp (Medical Components, Inc.)2017—
+3K112713Norfolk Medical-Sportport-Family of PortsNorfolk Medical Products, Inc.2011—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
198710
198940
199110
200020
200110
200430
200520

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201120
201410
201720
202010
202510
FIG. 1 — Lineage of K071846, 2000–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K040533EZ Huber Safety Infusion Set
Summary page 1
…ical, Inc CR Bard, Inc Name: EZ Huber Safety Infusion Set Power Loc Safety Infusion Set 510(k)#: K040533 K060812 Device Description: The EZ Huber Safety Infusion Set is used to access implanted septur…
Pfm Medical, Inc.2004—
*K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple
Summary page 1
…, Inc Name: EZ Huber Safety Infusion Set Power Loc Safety Infusion Set 510(k)#: K040533 K060812 Device Description: The EZ Huber Safety Infusion Set is used to access implanted septurns for the purpose of drug and IV infusion…
C.R. Bard, Inc.20061

What descends from it? (8)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K080544UnassignedMedcomp20086
K242763JetCan® Pro Safety Huber NeedlePfm Medical, Inc.20250

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 7 years and passes through 3 companies; a new generation was cleared every 12 months on median.
  • 11 of the 22 ancestors have a recall of any class.
  • Of its descendants, K080544 (Medcomp, 2008) has gone furthest, with 6 descendants of its own.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · FPA

11in 2025

2007: 162008: 182009: 102010: 232011: 122012: 212013: 132014: 222015: 172016: 122017: 172018: 42019: 72020: 102021: 132022: 142023: 142024: 72025: 112026 (partial year): 5
2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007: 75 days median2008: 89 days median2009: 166 days median2010: 120 days median2011: 87 days median2012: 96 days median2013: 90 days median2014: 89 days median2015: 123 days median2016: 195 days median2017: 240 days median2018: 177 days median2019: 161 days median2020: 327 days median2021: 186 days median2022: 213 days median2023: 340 days median2024: 244 days median2025: 225 days median2026 (partial year): 266 days median
2007high 340 (2023) · low 75 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FPA

98in 2025

2007: 172008: 152009: 1662010: 582011: 282012: 16, 4 Class I2013: 642014: 242015: 62016: 102017: 132018: 42019: 132020: 1072021: 12022: 9, 5 Class I2023: 12, 4 Class I2024: 13, 1 Class I2025: 98, 1 Class I2026 (partial year): 10, 2 Class I
2007high 166 (2009) · low 1 (2021)2026

Class I (17 since 2007) Class II/III not classified

Adverse event reports per year · FPA

34,506in 2025

2007: 1,4992008: 1,9412009: 2,5122010: 2,5372011: 4,4072012: 4,9302013: 4,6512014: 4,6952015: 6,6252016: 8,4702017: 6,4622018: 6,5742019: 11,2272020: 9,5632021: 10,4142022: 13,3932023: 10,9162024: 47,2102025: 34,506
2007high 47,210 (2024) · low 1,499 (2007)2025

MAUDE reports naming product code FPA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071675171,499
20081889151,941
2009101661662,512
201023120582,537
20111287284,407
2012219616 (4)4,930
20131390644,651
20142289244,695
20151712366,625
201612195108,470
201717240136,462
2018417746,574
201971611311,227
2020103271079,563
202113186110,414
2022142139 (5)13,393
20231434012 (4)10,916
2024724413 (1)47,210
20251122598 (1)34,506
2026526610 (2)—

What is it indicated for?

The EZ Huber Safety Infusion Set is a device used to administer fluids from a container to a patient's vascular system through an implanted port. The EZ Huber Safety Infusion Set incorporates an active safety feature that aids in the prevention of accidental needle sticks. The EZ Huber Safety Infusion Set 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 EZ Huber Safety Infusion Set is compatible with power injection procedures up to 300 psi.

Indications for use as stated in the FDA summary.

More from Pfm Medical, Inc.

25 FDA decisions under this applicant name. See the company

  • K242763JetCan® Pro Safety Huber NeedlePfm Medical, Inc. · 2025
  • K241278ASEPT® Glide Peritoneal Drainage SystemPfm Medical, Inc. · 2025
  • P120009/S004Nit-Occlud PdaPfm Medical, Inc. · 2024
  • K221779ASEPT Peritoneal Drainage SystemPfm Medical, Inc. · 2023
  • K213666NuCath Wedge Pressure CatheterPfm Medical, Inc. · 2022

Recent decisions in FPA

The FPA category page

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  • K252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF…Amsino International, Inc. · 2026
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https://510kreport.com/device/K071846 · printed Nov 5, 2026

Cite this page

510(k) Report. “K071846: Modification to EZ Huber Safety Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K071846

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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