510(k) · Cleared
Recalled · Class II · 2016Miniloc Safety Infusion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Specialized Health Products, Intl. · FPA Set, Administration, Intravascular
Cleared on May 12, 2005 as substantially equivalent to K013394 (Specialized Health Products, Inc., 2001) and 1 other predicate after a 64-day review. Its family tree reaches back 4 generations to 1989. 67 later devices descend from it. It has been recalled 2 times.
- Decided
- May 12, 2005
- Review
- 64 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 4 generations to K890127 (1989). 9 ancestors in all, the oldest K863606 (1986). 67 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK890127 Intravascular Administration SetMulti-Med, Inc. · 1989
- 3 generations backK993848 Millennium Huber Plus Safety Infusion SetMillennium Medical Distribution, Inc. · 2000 · Recalled
- 2 generations backK013394 Liftloc Safety Infusion SetSpecialized Health Products, Inc. · 2001 · Recalled
- 1 generation backK042234 Modification to: Liftloc Saftey Infusion SetSpecialty Health Products, Inc. · 2004
- This deviceK050600 Miniloc Safety Infusion SetSpecialized Health Products, Intl. · 2005
- Descendant · cites it directly · 66 of its ownK060812 Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex…C.R. Bard, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 20 of its ownK070003 Power Injectable Implantable Infusion Port with Silicone Lumen…Medcomp · 2007 · Recalled
- Descendant · 2 generations on · 20 of its ownK062414 Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 18 of its ownK070116 Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous…Smiths Medical MD, Inc. · 2007
- Descendant · 2 generations on · 13 of its ownK073050 Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · Recalled
Showing 5 of 67 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 67 · See all- K060812Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-MultipleC.R. Bard, Inc. · 2006 · cites it directly66descendants
- K070003Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and…Medcomp · 2007 · 2 generations on20descendants
- K062414Vortex CT Port Access System and Lifeguard Safety Infusion SetRita Medical Systems, Inc. · 2007 · 2 generations on20descendants
- K070116Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems and Power…Smiths Medical MD, Inc. · 2007 · 2 generations on18descendants
- K073050Safestep Max Power-Injectable Infusion SetSpecialized Health Products International, Inc. · 2008 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K890127 | Intravascular Administration Set | Multi-Med, Inc. | 1989 | — |
| −3 | K993848 | Millennium Huber Plus Safety Infusion Set | Millennium Medical Distribution, Inc. | 2000 | 2 |
| −2 | K013394 | Liftloc Safety Infusion Set | Specialized Health Products, Inc. | 2001 | 1 |
| −1 | K042234 | Modification to: Liftloc Saftey Infusion Set | Specialty Health Products, Inc. | 2004 | — |
| 0 (this device) | K050600 | Miniloc Safety Infusion Set | Specialized Health Products, Intl. | 2005 | — |
| +1 | K060812 | Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple | C.R. Bard, Inc. | 2006 | 1 |
| +2 | K070003 | Power Injectable Implantable Infusion Port with Silicone Lumen (Attachable and… | Medcomp | 2007 | 3 |
| +2 | K062414 | Vortex CT Port Access System and Lifeguard Safety Infusion Set | Rita Medical Systems, Inc. | 2007 | 2 |
| +2 | K070116 | Power Port-a-Cath and Power Port-a-Cath II; Implantable Venous Access Systems… | Smiths Medical MD, Inc. | 2007 | — |
| +2 | K073050 | Safestep Max Power-Injectable Infusion Set | Specialized Health Products International, Inc. | 2008 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K013394 | Liftloc Safety Infusion SetSummary page 2…rates as a standard Huber needle intravascular administration set, as does the Specialized Health Product's Safety Infusion set: LifiLoc® Safety Infusion Set (K013394 and K042234). * The MiniLocTM Safety Infusion Set is manufactured from the same or similar materials as the predicate de… | 2001 |
| * | K042234 | Modification to: Liftloc Saftey Infusion SetSummary page 1…ation Number: 21 CFR 880.5440 STATEMENT OF SUBSTANTIAL EQUIVALENCE: LWLoc®k Safety Infusion Set, Specialized Health Products, Inc., Bountiful, UT 84054, (KO]3394 and K042234). DEVICE DESCRIPTION: The MiniLocTM Safety Infusion Set is a standard non-coring Huber type needle and administration set wi… | 2004 |
What descends from it? (67)
See all 671 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060812 | Powerport (TM)Implanted Titanium Port W/8 FR. Chronoflex Catheter-Multiple | 2006 | 66 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 19, 2016 | Class II | Z-0985-2017 | Mixed-up of materials/components | Bard Access Systems announces a voluntary field action for the SafeStep Huber Needle Set with Y-Injection Site and MiniLoc Safety Infusion Set Winged without Y-Injection Site devices because sets may contain one or more units where the… |
| Aug 8, 2014 | Class II | Z-1273-2015 | Nonconforming Material/Component | Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit open seals, which could impact product sterility. Bard includes these pouched syringes, attached to some configurations of PICC kits, Port Access kits (PAK)… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 4 of the 9 ancestors have a recall of any class.
- Of its descendants, K060812 (C.R. Bard, Inc., 2006) has gone furthest, with 66 descendants of its own.
- 2 other devices also cite its predicate K013394.
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 MiniLoc TM Safety Infusion Set device is a safety intravascular administration set with a non-coring right angle Huber needle, used to access surgically implanted vascular pods. The integral MiniLoc TM Safety Infusion Set safety mechanism is manually activated during the removal of the MiniLoc TM Safety Infusion Set needle from a surgically implanted vascular port. The safety mechanism reduces the risk of accidental needlestick injuries by shielding…
Read the full statement (125 words)
The MiniLoc TM Safety Infusion Set device is a safety intravascular administration set with a non-coring right angle Huber needle, used to access surgically implanted vascular pods.
The integral MiniLoc TM Safety Infusion Set safety mechanism is manually activated during the removal of the MiniLoc TM 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 MiniLoc TM Safety Infusion Set is intended for use in the administration of fluids and drugs, as well as blood sampling through surgically implanted pods.
The MiniLocTM Safety Infusion Set will be marketed as a sterile, non-pyrogenic, single use device.
The MiniLoc TM Safety Infusion Set may be used in any appropriate patient population.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050600 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050600: Miniloc 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/K050600
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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