510(k) Report

510(k) · Cleared

Cleared

Jetcan Huber Neeedle Set

K002471510(k) TraditionalCleared Oct 19, 200069-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 Produkte Fur Die Medizin AG · FPA Set, Administration, Intravascular

Cleared on Oct 19, 2000 after a 69-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 10 later devices descend from it.

Decided
Oct 19, 2000
Review
69 days
Class
Class II
Product code
FPA
Recalls
None
Predicates
0

10 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2007: 1 descendant cleared2008: 1 descendant cleared2025: 1 descendant cleared2011: 2 descendants cleared2014: 1 descendant cleared2017: 2 descendants cleared2020: 1 descendant cleared200020052010201520202025
  1. This deviceK002471 Jetcan Huber Neeedle SetPfm Produkte Fur Die Medizin AG · 2000
  2. Descendant · cites it directly · 9 of its ownK040533 EZ Huber Safety Infusion SetPfm Medical, Inc. · 2004
  3. Descendant · 2 generations on · 8 of its ownK071846 Modification to EZ Huber Safety Infusion SetPfm Medical, Inc. · 2007
  4. Descendant · 3 generations on · 6 of its ownK080544 UnassignedMedcomp · 2008
  5. Descendant · 4 generations on · 2 of its ownK132880 Medcomp Power Injectable Safety Huber NeedleMedical Components, Inc. · 2014
  6. Descendant · 4 generations on · 2 of its ownK111101 Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2004: 12007: 12008: 12011: 22014: 12017: 22020: 12025: 1
2004high 2 (2011) · low 0 (2005)2026

Most influential descendants

Showing 5 of 10 · See all
  • K040533EZ Huber Safety Infusion SetPfm Medical, Inc. · 2004 · cites it directly9descendants
  • K071846Modification to EZ Huber Safety Infusion SetPfm Medical, Inc. · 2007 · 2 generations on8descendants
  • K080544UnassignedMedcomp · 2008 · 3 generations on6descendants
  • K132880Medcomp Power Injectable Safety Huber NeedleMedical Components, Inc. · 2014 · 4 generations on2descendants
  • K111101Norport CT-PC, Lucent Non-Coring Needel Infusion SetNorfolk Medical · 2011 · 4 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

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

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200710
200810
201120
201410
201720
202010
202510
FIG. 1 — Lineage of K002471, 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), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (10)

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

NumberDeviceApplicantDecidedDescendants
K040533EZ Huber Safety Infusion SetPfm Medical, Inc.20049

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?

  • Of its descendants, K040533 (Pfm Medical, Inc., 2004) has gone furthest, with 9 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)—

More from Pfm Produkte Fur Die Medizin AG

3 FDA decisions under this applicant name. See the company

  • K011783Multi-Snare SetPfm Produkte Fur Die Medizin AG · 20021 recall
  • K001716Redon SetPfm Produkte Fur Die Medizin AG · 2000

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https://510kreport.com/device/K002471 · printed Nov 4, 2026

Cite this page

510(k) Report. “K002471: Jetcan Huber Neeedle Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K002471

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026