510(k) Report

510(k) · Cleared

Cleared

EZ Huber Safety Infusion Set

K040533510(k) TraditionalCleared Sep 17, 2004200-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 Sep 17, 2004 as substantially equivalent to K002471 (Pfm Produkte Fur Die Medizin AG, 2000) after a 200-day review. Its family tree reaches back 1 generation to 2000. 9 later devices descend from it.

Decided
Sep 17, 2004
Review
200 days
Class
Class II
Product code
FPA
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K002471 (2000). 9 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2008: 1 descendant cleared2025: 1 descendant cleared2011: 2 descendants cleared2014: 1 descendant cleared2017: 2 descendants cleared2020: 1 descendant clearedK002471 · Jetcan Huber Neeedle Set · Pfm Produkte Fur Die Medizin AG · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 2 descendants5 generations forward: 2 descendants K002471 · Jetcan Huber Neeedle Set · Pfm Produkte Fur Die Medizin AG · 20000+5
  1. Root · 1 generation backK002471 Jetcan Huber Neeedle SetPfm Produkte Fur Die Medizin AG · 2000
  2. This deviceK040533 EZ Huber Safety Infusion SetPfm Medical, Inc. · 2004
  3. Descendant · cites it directly · 8 of its ownK071846 Modification to EZ Huber Safety Infusion SetPfm Medical, Inc. · 2007
  4. Descendant · 2 generations on · 6 of its ownK080544 UnassignedMedcomp · 2008
  5. Descendant · 3 generations on · 2 of its ownK132880 Medcomp Power Injectable Safety Huber NeedleMedical Components, Inc. · 2014
  6. Descendant · 3 generations on · 2 of its ownK111101 Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011
  7. Descendant · 4 generations on · 1 of its ownK162271 Pro-Lock CT Safety Infusion SetMedcomp (Medical Components, Inc.) · 2017

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2007: 12008: 12011: 22014: 12017: 22020: 12025: 1
2007high 2 (2011) · low 0 (2009)2026

Most influential descendants

Showing 5 of 9 · See all
  • K071846Modification to EZ Huber Safety Infusion SetPfm Medical, Inc. · 2007 · cites it directly8descendants
  • K080544UnassignedMedcomp · 2008 · 2 generations on6descendants
  • K132880Medcomp Power Injectable Safety Huber NeedleMedical Components, Inc. · 2014 · 3 generations on2descendants
  • K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011 · 3 generations on2descendants
  • K162271Pro-Lock CT Safety Infusion SetMedcomp (Medical Components, Inc.) · 2017 · 4 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K002471Jetcan Huber Neeedle SetPfm Produkte Fur Die Medizin AG2000—
0 (this device)K040533EZ Huber Safety Infusion SetPfm Medical, Inc.2004—
+1K071846Modification to EZ Huber Safety Infusion SetPfm Medical, Inc.2007—
+2K080544UnassignedMedcomp2008—
+3K132880Medcomp Power Injectable Safety Huber NeedleMedical Components, Inc.2014—
+3K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical2011—
+4K162271Pro-Lock CT Safety Infusion SetMedcomp (Medical Components, Inc.)2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200810
201120
201410
201720
202010
202510
FIG. 1 — Lineage of K040533, 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K002471Jetcan Huber Neeedle Set
Summary page 1
…Administration Set Classification Name: Same Equivalent Devices: Manufacturer: pfm Medical, Inc Name: Jetcan Huber Needle Set 51 0(k) 4:K002471 Device Description: The EZ H-uber Safety Infusion Set is a single use, sterile and non-pyrogenic device intended for use as an…
Pfm Produkte Fur Die Medizin AG2000—

What descends from it? (9)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K071846Modification to EZ Huber Safety Infusion SetPfm Medical, Inc.20078

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?

  • Its one ancestor has no recall.
  • Of its descendants, K071846 (Pfm Medical, Inc., 2007) has gone furthest, with 8 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.

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.

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/K040533 · printed Nov 6, 2026

Cite this page

510(k) Report. “K040533: EZ Huber 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/K040533

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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