510(k) Report

510(k) · Cleared

Cleared

Luther Safety Huber Needle Set

K021565510(k) TraditionalCleared Nov 14, 2002185-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

Luther Research Partners · FPA Set, Administration, Intravascular

Cleared on Nov 14, 2002 as substantially equivalent to K993848 (Millennium Medical Distribution, Inc., 2000) after a 185-day review. Its family tree reaches back 2 generations to 1989. 17 later devices descend from it.

Decided
Nov 14, 2002
Review
185 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. 17 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1991: 1 other ancestor1989: 3 other ancestors2004: 2 descendants cleared2008: 1 descendant cleared2003: 1 descendant cleared2009: 1 descendant cleared2016: 1 descendant cleared2017: 2 descendants cleared2014: 1 descendant cleared2021: 3 descendants cleared2023: 1 descendant cleared2024: 1 descendant cleared2026: 1 descendant cleared2025: 2 descendants clearedK890127 · Intravascular Administration Set · Multi-Med, Inc. · 1989K993848 · Millennium Huber Plus Safety Infusion Set · Millennium Medical Distribution, Inc. · 2000 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 4 other ancestors 1 generation forward: 4 descendants2 generations forward: 3 descendants3 generations forward: 4 descendants4 generations forward: 5 descendants5 generations forward: 1 descendant K993848 · Millennium Huber Plus Safety Infusion Set · Millennium Medical Distribution, Inc. · 2000 · recalledK890127 · Intravascular Administration Set · Multi-Med, Inc. · 19890+5
  1. Root · 2 generations backK890127 Intravascular Administration SetMulti-Med, Inc. · 1989
  2. 1 generation backK993848 Millennium Huber Plus Safety Infusion SetMillennium Medical Distribution, Inc. · 2000 · Recalled
  3. This deviceK021565 Luther Safety Huber Needle SetLuther Research Partners · 2002
  4. Descendant · cites it directly · 14 of its ownK040527 Low Profile Luther Safety HuberLuther Needlesafe Products, Inc. · 2004 · Recalled
  5. Descendant · cites it directly · 13 of its ownK073050 Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · Recalled
  6. Descendant · 2 generations on · 6 of its ownK170897 Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety…B.Braun Medical, Inc. · 2017
  7. Descendant · cites it directly · 3 of its ownK032934 MPS Acacia Safeguard Huber DeviceMps Acacia · 2003
  8. Descendant · 3 generations on · 2 of its ownK230715 Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2023

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2003: 12004: 22008: 12009: 12014: 12016: 12017: 22021: 32023: 12024: 12025: 22026: 1
2003high 3 (2021) · low 0 (2005)2026

Most influential descendants

Showing 5 of 17 · See all
  • K040527Low Profile Luther Safety HuberLuther Needlesafe Products, Inc. · 2004 · cites it directly14descendants
  • K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · cites it directly13descendants
  • K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with…B.Braun Medical, Inc. · 2017 · 2 generations on6descendants
  • K032934MPS Acacia Safeguard Huber DeviceMps Acacia · 2003 · cites it directly3descendants
  • K230715Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd. · 2023 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K890127Intravascular Administration SetMulti-Med, Inc.1989—
−1K993848Millennium Huber Plus Safety Infusion SetMillennium Medical Distribution, Inc.20002
0 (this device)K021565Luther Safety Huber Needle SetLuther Research Partners2002—
+1K040527Low Profile Luther Safety HuberLuther Needlesafe Products, Inc.20042
+1K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc.20082
+2K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle…B.Braun Medical, Inc.2017—
+1K032934MPS Acacia Safeguard Huber DeviceMps Acacia2003—
+3K230715Promisemed Safety Huber NeedlePromisemed Hangzhou Meditech Co., Ltd.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198930
199110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200420
200810
200910
201410
201610
201720
202130
202310
202410
202520
202610
FIG. 1 — Lineage of K021565, 1989–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (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
*K993848Millennium Huber Plus Safety Infusion Set
Summary page 1
…Safety Huber Needle and Administration Set Predicate Device: Millennium Huber Plus Safety Infusion Set K993848 Device Descrbtion: The Luther Safety Huber Needle Set is a standard right angle Huber needle and administration…
Millennium Medical Distribution, Inc.20002

Also cleared against K993848: 6 other devices →

What descends from it? (17)

See all 17

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

NumberDeviceApplicantDecidedDescendants
K040527Low Profile Luther Safety HuberLuther Needlesafe Products, Inc.200414
K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc.200813
K032934MPS Acacia Safeguard Huber DeviceMps Acacia20033
K042666Luth-All Sub-Q Needle SetLuth-All Medical Products, LLC20040

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 13 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, K040527 (Luther Needlesafe Products, Inc., 2004) has gone furthest, with 14 descendants of its own.
  • 6 other devices also cite its predicate K993848.

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 Luther Safety Huber Needle Set is a device intended to administer drugs to a patient from a container through a subcutaneous implanted port. The Huber Needle safety needle cover is manually activated. When the safety feature is activated, the device is designed to aid in the prevention of accidental needle sticks.

Indications for use as stated in the FDA summary.

Also cleared against K993848

6 other devices cite the same predicate.

  • K170881ISP Safety Huber Needle Infusion SetInfusion Safety Products, Inc. · 2017
  • K051009Huber Clear Safety Infusion SetNow Medical Distribution, Inc. · 2005
  • K032934MPS Acacia Safeguard Huber DeviceMps Acacia · 2003
  • K021488Surecan Safety Huber Needle Infusion SetsB.Braun Medical, Inc. · 2002
  • K013871Lifeguard Safety Infusion SetHorizon Medical Products, Inc. · 20023 recalls
  • K013394Liftloc Safety Infusion SetSpecialized Health Products, Inc. · 20011 recall

Recent decisions in FPA

The FPA category page

  • K260261Gravity Blood Sets with 200µm FilterB.Braun Medical, Inc. · 2026
  • K254123Ecomed Disposable Administration SetsEcomed Solutions, LLC · 2026
  • K261530iiSure Infusion SetDeka Research and Development · 2026
  • 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
  • K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc. · 2026

https://510kreport.com/device/K021565 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021565: Luther Safety Huber Needle Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021565

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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