510(k) Report

510(k) · Cleared

Cleared

Modification to: Liftloc Saftey Infusion Set

K042234510(k) SpecialCleared Sep 8, 200421-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

Specialty Health Products, Inc. · FPA Set, Administration, Intravascular

Cleared on Sep 8, 2004 as substantially equivalent to K013394 (Specialized Health Products, Inc., 2001) after a 21-day review. Its family tree reaches back 3 generations to 1989. 68 later devices descend from it.

Decided
Sep 8, 2004
Review
21 days
Class
Class II
Product code
FPA
Recalls
None
Predicates
1

Its longest line of descent runs back 3 generations to K890127 (1989). 8 ancestors in all, the oldest K863606 (1986). 68 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1986: 1 other ancestor1991: 1 other ancestor1989: 3 other ancestors2005: 1 descendant cleared2006: 1 descendant cleared2007: 11 descendants cleared2019: 2 descendants cleared2008: 7 descendants cleared2009: 2 descendants cleared2011: 5 descendants cleared2010: 2 descendants cleared2025: 6 descendants cleared2023: 3 descendants cleared2024: 2 descendants cleared2014: 3 descendants cleared2013: 6 descendants cleared2012: 3 descendants cleared2016: 1 descendant cleared2017: 4 descendants cleared2015: 2 descendants cleared2020: 2 descendants cleared2021: 3 descendants cleared2026: 2 descendants clearedK890127 · 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 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 4 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 19 descendants4 generations forward: 22 descendants5 generations forward: 13 descendants6 generations forward: 9 descendants7 generations forward: 3 descendants 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+5
  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 deviceK042234 Modification to: Liftloc Saftey Infusion SetSpecialty Health Products, Inc. · 2004
  5. Descendant · cites it directly · 67 of its ownK050600 Miniloc Safety Infusion SetSpecialized Health Products, Intl. · 2005 · Recalled
  6. Descendant · 2 generations on · 66 of its ownK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
  7. Descendant · 3 generations on · 20 of its ownK070003 Power Injectable Implantable Infusion Port with Silicone Lumen…Medcomp · 2007 · Recalled
  8. Descendant · 3 generations on · 20 of its ownK062414 Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · Recalled
  9. Descendant · 3 generations on · 18 of its ownK070116 Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous…Smiths Medical MD, Inc. · 2007

Showing 5 of 68 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12007: 112008: 72009: 22010: 22011: 52012: 32013: 62014: 32015: 22016: 12017: 42019: 22020: 22021: 32023: 32024: 22025: 62026: 2
2005high 11 (2007) · low 0 (2018)2026

Most influential descendants

Showing 5 of 68 · See all
  • K050600Miniloc Safety Infusion SetSpecialized Health Products, Intl. · 2005 · cites it directly67descendants
  • K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc. · 2006 · 2 generations on66descendants
  • K070003Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and…Medcomp · 2007 · 3 generations on20descendants
  • K062414Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · 3 generations on20descendants
  • K070116Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power…Smiths Medical MD, Inc. · 2007 · 3 generations on18descendants
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)K042234Modification to: Liftloc Saftey Infusion SetSpecialty Health Products, Inc.2004—
+1K050600Miniloc Safety Infusion SetSpecialized Health Products, Intl.20052
+2K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc.20061
+3K070003Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and…Medcomp20073
+3K062414Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc.20072
+3K070116Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems…Smiths Medical MD, Inc.2007—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198610
198930
199110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
2007110
200870
200920
201020
201150
201230
201360
201430
201520
201610
201740
201920
202020
202130
202330
202420
202560
202620
FIG. 1 — Lineage of K042234, 1989–2026Source: 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? (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
*K013394Liftloc Safety Infusion Set
Summary page 1
…FPA Regulation Number: 21 CER 880.5440 PREDICATE DEVICE: L~I/Loe® Safety~ In/iision Set (K013394), Specialized Health Products®g, Inc., Bountiful, UT 8401 0. DEVICE DESCRIPTION AND COMPARISON TO CLEARED DEVICE: The L…
Specialized Health Products, Inc.20011

Also cleared against K013394: 2 other devices →

What descends from it? (68)

See all 68

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

NumberDeviceApplicantDecidedDescendants
K050600Miniloc Safety Infusion SetSpecialized Health Products, Intl.200567

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 15 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
  • 4 of the 8 ancestors have a recall of any class.
  • Of its descendants, K050600 (Specialized Health Products, Intl., 2005) has gone furthest, with 67 descendants of its own.
  • 2 other devices also cite its predicate K013394.

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 LiftLoc® Safety Infusion Set device is a safety intravascular administration set with a non-coring right angle Huber needle, used to access surgically implanted vascular ports. The integral LiftLoc® Safety Infusion Set safety mechanism is manually activated during the removal of the LiftLoc® Safety Infusion Set needle from a surgically implanted vascular port. The safety mechanism reduces the risk of accidental needlestick injuries by shielding the…

Read the full statement (119 words)

The LiftLoc® Safety Infusion Set device is a safety intravascular administration set with a non-coring right angle Huber needle, used to access surgically implanted vascular ports.

The integral LiftLoc® Safety Infusion Set safety mechanism is manually activated during the removal of the LiftLoc® Safety Infusion Set needle from a surgically implanted vascular port. The safety mechanism reduces the risk of accidental needlestick injuries by shielding the needle.

The LiftLoc® Safety Infusion Set is intended for use in the administration of fluids and drugs, or blood sampling through surgically implanted vascular ports.

The LiftLoc® Safety Infusion Set will be marketed as a sterile, non-pyrogenic, single use device.

The LiftLoc® Safety Infusion Set may be used in any appropriate patient population.

Indications for use as stated in the FDA summary.

Also cleared against K013394

2 other devices cite the same predicate.

  • K050600Miniloc Safety Infusion SetSpecialized Health Products, Intl. · 20052 recalls
  • K021488Surecan Safety Huber Needle Infusion SetsB.Braun Medical, Inc. · 2002

More from Specialty Health Products, Inc.

2 FDA decisions under this applicant name. See the company

  • K891585Hydro-San Colonic Irrigation SystemSpecialty Health Products, Inc. · 1989

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/K042234 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042234: Modification to: Liftloc Saftey Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042234

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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