510(k) · Cleared
Recalled · 2003Liftloc Safety Infusion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Specialized Health Products, Inc. · FPA Set, Administration, Intravascular
Cleared on Nov 8, 2001 as substantially equivalent to K993848 (Millennium Medical Distribution, Inc., 2000) and 1 other predicate after a 24-day review. Its family tree reaches back 2 generations to 1989. 70 later devices descend from it. It has been recalled once.
- Decided
- Nov 8, 2001
- Review
- 24 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 2 generations to K890127 (1989). 7 ancestors in all, the oldest K863606 (1986). 70 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK890127 Intravascular Administration SetMulti-Med, Inc. · 1989
- 1 generation backK993848 Millennium Huber Plus Safety Infusion SetMillennium Medical Distribution, Inc. · 2000 · Recalled
- This deviceK013394 Liftloc Safety Infusion SetSpecialized Health Products, Inc. · 2001
- Descendant · cites it directly · 68 of its ownK042234 Modification to: Liftloc Saftey Infusion SetSpecialty Health Products, Inc. · 2004
- Descendant · cites it directly · 67 of its ownK050600 Miniloc Safety Infusion SetSpecialized Health Products, Intl. · 2005 · Recalled
- Descendant · 2 generations on · 66 of its ownK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
- Descendant · 3 generations on · 20 of its ownK070003 Power Injectable Implantable Infusion Port with Silicone Lumen…Medcomp · 2007 · Recalled
- Descendant · 3 generations on · 20 of its ownK062414 Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · Recalled
Showing 5 of 70 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 70 · See all- K042234Modification to: Liftloc Saftey Infusion SetSpecialty Health Products, Inc. · 2004 · cites it directly68descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K890127 | Intravascular Administration Set | Multi-Med, Inc. | 1989 | — |
| −1 | K993848 | Millennium Huber Plus Safety Infusion Set | Millennium Medical Distribution, Inc. | 2000 | 2 |
| 0 (this device) | K013394 | Liftloc Safety Infusion Set | Specialized Health Products, Inc. | 2001 | — |
| +1 | K042234 | Modification to: Liftloc Saftey Infusion Set | Specialty Health Products, Inc. | 2004 | — |
| +1 | K050600 | Miniloc Safety Infusion Set | Specialized Health Products, Intl. | 2005 | 2 |
| +2 | K060812 | Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple | C.R. Bard, Inc. | 2006 | 1 |
| +3 | K070003 | Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and… | Medcomp | 2007 | 3 |
| +3 | K062414 | Vortex CT Port Access System and Lifeguard Safety Infusion Set | Rita Medical Systems, Inc. | 2007 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1989 | 3 | 0 |
| 1991 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 11 | 0 |
| 2008 | 7 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 6 | 0 |
| 2026 | 2 | 0 |
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 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K993848 | Millennium Huber Plus Safety Infusion SetSummary page 1…Hospital and Personal Use Class: I Procode: FPA Regulation Number: 21 CFR 880.5440 STATEMENT OF SUBSTANTIAL EQUIVALENCE: e Millennium Huber Plus Safety Infusion Set (K993848), Millennium Medical Distribution, Inc., Kennett Square, PA. e Butterfly Non-coring Needle Set (K863606), Cormed, Inc., Sub. C.R.… | 2000 |
| * | K863606 | Butterfly Non-Coring Needle SetSummary page 1…TANTIAL EQUIVALENCE: e Millennium Huber Plus Safety Infusion Set (K993848), Millennium Medical Distribution, Inc., Kennett Square, PA. e Butterfly Non-coring Needle Set (K863606), Cormed, Inc., Sub. C.R. Bard, Inc.(currently marketed by Bard Access Systems, a division of C.R. Bard, as Winged Infusion Set),… | 1986 |
What descends from it? (70)
See all 703 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 17, 2003 | Not classified | Z-0837-03 | Other | Pouch seals on Safety Infusion Sets may be defective, possibly compromising sterility. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 11.0 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K042234 (Specialty Health Products, Inc., 2004) has gone furthest, with 68 descendants of its own.
- 6 other devices also cite its predicate K993848.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013394 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013394: Liftloc Safety Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013394
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026