510(k) · Cleared
Recalled · Class II · 2017Lifeguard Safety Infusion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Horizon Medical Products, Inc. · FPA Set, Administration, Intravascular
Cleared on Mar 29, 2002 as substantially equivalent to K921674 (Strato Medical Corp., 1992) and 1 other predicate after a 128-day review. Its family tree reaches back 2 generations to 1989. 24 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 29, 2002
- Review
- 128 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 2 generations to K890127 (1989). 7 ancestors in all. 24 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 deviceK013871 Lifeguard Safety Infusion SetHorizon Medical Products, Inc. · 2002
- Descendant · cites it directly · 20 of its ownK062414 Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 13 of its ownK073050 Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 6 of its ownK170897 Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety…B.Braun Medical, Inc. · 2017
- Descendant · 2 generations on · 5 of its ownK072375 Smartport CT MP Port Access System and Lifeguard CT Safety Infusion…AngioDynamics, Inc. · 2007
- Descendant · 2 generations on · 4 of its ownK081472 Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium…AngioDynamics, Inc. · 2008 · Recalled
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K062414Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · cites it directly20descendants
- K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · 2 generations on13descendants
- K170897Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with…B.Braun Medical, Inc. · 2017 · 3 generations on6descendants
- K072375Smartport CT MP Port Access System and Lifeguard CT Safety Infusion SetAngioDynamics, Inc. · 2007 · 2 generations on5descendants
- K081472Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low Profile…AngioDynamics, Inc. · 2008 · 2 generations on4descendants
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) | K013871 | Lifeguard Safety Infusion Set | Horizon Medical Products, Inc. | 2002 | — |
| +1 | K062414 | Vortex CT Port Access System and Lifeguard Safety Infusion Set | Rita Medical Systems, Inc. | 2007 | 2 |
| +2 | K073050 | Safestep Max Power-Injectable Infusion Set | Specialized Health Products International, Inc. | 2008 | 2 |
| +3 | K170897 | Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle… | B.Braun Medical, Inc. | 2017 | — |
| +2 | K072375 | Smartport CT MP Port Access System and Lifeguard CT Safety Infusion Set | AngioDynamics, Inc. | 2007 | — |
| +2 | K081472 | Smartport CT Vortex; LP Titanium, Single Plastic, Single Titanium, Triumph Low… | AngioDynamics, Inc. | 2008 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 3 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
| 2011 | 3 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K921674 | Lifeport Infusion Set and Infusion Set W/ Y SiteSummary page 1…ces To Which Substantial Equivalence Is Claimed To: The LifeGuard™ Safety Infusion Set is substantially equivalent to e Horizon Medical Products LifePort® Infusion Set (K921674) e Millennium Safety Non-coring Plus Infusion Set (K993848) Device Description: The LifeGuard™ Infusion Set is a standard 90°… | 1992 |
| * | K993848 | Millennium Huber Plus Safety Infusion SetSummary page 1…Guard™ Safety Infusion Set is substantially equivalent to e Horizon Medical Products LifePort® Infusion Set (K921674) e Millennium Safety Non-coring Plus Infusion Set (K993848) Device Description: The LifeGuard™ Infusion Set is a standard 90° non-coring needle intravascular administration set with a sh… | 2000 |
What descends from it? (24)
See all 243 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 |
|---|---|---|---|---|
| Jul 24, 2017 | Class II | Z-0679-2018 | Under Investigation by firm | Vygon is conducting a voluntary recall of the products and lots listed in this recall, being initiated because our Tyvek supplier has notified Vygon of issues with their product, specifically the Tyvek may not be coated completely causing… |
| Jan 21, 2013 | Class II | Z-0914-2013 | Under Investigation by firm | The label on the device states that the item number is CLGY-2210 when the item number on the device label should read CLGY-2010. This is a 20Ga Huber needle set; however, the product label states the pouch contains a 22Ga set. |
| Nov 16, 2010 | Not classified | Z-1327-2011 | Vendor change control | Routine testing conducted to challenge the success of sterilization was not fully completed for sterile products. |
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 7 ancestors have a recall of any class.
- Of its descendants, K062414 (Rita Medical Systems, Inc., 2007) has gone furthest, with 20 descendants of its own.
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 LifeGuard™ Safety Infusion Set is used to access implanted vascular ports
to administer fluids and/or to withdraw blood. The LifeGuard™ Safety Infusion
Set facilitates safe removal of the needle by encapsulating the needle during
vascular port de-accessing to help prevent needlestick injuries.
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/K013871 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013871: Lifeguard Safety Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013871
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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