510(k) Report

510(k) · Cleared

Cleared

Surecan Safety Huber Needle Infusion Sets

K021488510(k) TraditionalCleared Jul 8, 200261-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

B.Braun Medical, Inc. · FPA Set, Administration, Intravascular

Cleared on Jul 8, 2002 as substantially equivalent to K993848 (Millennium Medical Distribution, Inc., 2000) and 3 other predicates after a 61-day review. Its family tree reaches back 3 generations to 1989.

Decided
Jul 8, 2002
Review
61 days
Class
Class II
Product code
FPA
Recalls
None
Predicates
4

Its longest line of descent runs back 3 generations to K890127 (1989). 12 ancestors in all, the oldest K801941 (1980). No later device cites it as a predicate yet.

Other ancestors, by year cleared 1999: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestor1991: 1 other ancestor1989: 3 other ancestors1986: 1 other ancestor1980: 1 other ancestorK890127 · Intravascular Administration Set · Multi-Med, Inc. · 1989K993848 · Millennium Huber Plus Safety Infusion Set · Millennium Medical Distribution, Inc. · 2000 · recalledK013394 · Liftloc Safety Infusion Set · Specialized Health Products, Inc. · 2001 · recalled19801985199019952000
Other ancestors, by generation 1 generation back: 2 other ancestors2 generations back: 7 other ancestors K013394 · Liftloc Safety Infusion Set · Specialized Health Products, Inc. · 2001 · recalledK993848 · Millennium Huber Plus Safety Infusion Set · Millennium Medical Distribution, Inc. · 2000 · recalledK890127 · Intravascular Administration Set · Multi-Med, Inc. · 19890
  1. Root · 3 generations backK890127 Intravascular Administration SetMulti-Med, Inc. · 1989
  2. 2 generations backK993848 Millennium Huber Plus Safety Infusion SetMillennium Medical Distribution, Inc. · 2000 · Recalled
  3. 1 generation backK013394 Liftloc Safety Infusion SetSpecialized Health Products, Inc. · 2001 · Recalled
  4. This deviceK021488 Surecan Safety Huber Needle Infusion SetsB.Braun Medical, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K890127Intravascular Administration SetMulti-Med, Inc.1989—
−2K993848Millennium Huber Plus Safety Infusion SetMillennium Medical Distribution, Inc.20002
−1K013394Liftloc Safety Infusion SetSpecialized Health Products, Inc.20011
0 (this device)K021488Surecan Safety Huber Needle Infusion SetsB.Braun Medical, Inc.2002—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198610
198930
199110
199510
199610
199910
FIG. 1 — Lineage of K021488, 1989–2002Source: 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? (4)

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
…FPA PREDICATE DEVICE: Millennium Medical Distribution Inc. Millennium Huber Plus Safety Infusion Set, K993848 Specialized Health Products, Inc. LiftlocTMSafety Infusion Set, KO13394…
Millennium Medical Distribution, Inc.20002
*K013394Liftloc Safety Infusion Set
Summary page 2
…Millennium Huber Plus Safety Infusion Set, K993848 and to Specialized Health Products, Inc. LiftlocTMSafety Infusion Set, K013394. The Ultrasite8 Valve and the safety clip mechanism that is a component of the SurecanTM Safety H…
Specialized Health Products, Inc.20011
*K982805Introcan Safety IV Catheter
Summary page 1
…LiftlocTMSafety Infusion Set, KO13394 B. Braun Medical Inc.’s Introcana SafetyTM IV Catheter, K982805 V2 Injection Site (UltrasiteB) valve, K955585 DESCRIPTION:…
B.Braun Medical, Inc.19991
*K955585V2 Injection Site
Summary page 1
…Introcana SafetyTM IV Catheter, K982805 V2 Injection Site (UltrasiteB) valve, K955585 DESCRIPTION: The SurecanTMSafety Huber Needle Infusion Set consists of a standard right angle n…
B.Braun Medical, Inc.199627

Also cleared against K993848: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 4 companies; a new generation was cleared every 1.8 years on median.
  • 7 of the 12 ancestors have a recall of any class.
  • 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 Surecan™ Safety Huber Needle Infusion Set is a passive needlestick prevention device which is designed to minimize inadvertent needlesticks. The device is intended to provide implanted subcutaneous port access, used in conjunction with IV administration of chemotherapy and other injectable drugs and/or to withdraw blood.

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
  • K021565Luther Safety Huber Needle SetLuther Research Partners · 2002
  • K013871Lifeguard Safety Infusion SetHorizon Medical Products, Inc. · 20023 recalls
  • K013394Liftloc Safety Infusion SetSpecialized Health Products, Inc. · 20011 recall

More from B.Braun Medical, Inc.

151 FDA decisions under this applicant name. See the company

  • K260261Gravity Blood Sets with 200µm FilterB.Braun Medical, Inc. · 2026
  • K254111Irrigation/Urology SetsB.Braun Medical, Inc. · 2026
  • K253235Introcan Safety® Deep Access XL IV CatheterB.Braun Medical, Inc. · 2026
  • K243392Infusomat® Space Volumetric Infusion Pump Administration SetsB.Braun Medical, Inc. · 2025
  • K240578VenaTech® LP Vena Cava Filter System and VenaTech® Convertible Vena Cava Filter SystemB.Braun Medical, Inc. · 2024

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/K021488 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021488: Surecan Safety Huber Needle Infusion Sets.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021488

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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