510(k) · Cleared
ClearedPolyurethane Infusion Catheter, Alpha Cath, Model PAC20, and Polyurethane Infusion Catheter, Multi Drip, Model PMD20-6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Infusion, Inc. · MED Sterilant, Medical Devices
Cleared on Jul 3, 2006 as substantially equivalent to K021964 (Advanced Infusion, Inc., 2002) and 3 other predicates after a 49-day review. Its family tree reaches back 8 generations to 1990. 1 of the 32 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 3, 2006
- Review
- 49 days
- Class
- Class II
- Product code
- MED
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K896422 (1990). 31 ancestors in all, the oldest K813186 (1981). No later device cites it as a predicate yet. 1 of the 32 devices in this family, counting this one, has a Class I recall.
- Root · 8 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 7 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
- 6 generations backK982946 Painbuster Infusion KitI-Flow Corp. · 1998
- 5 generations backK984502 Nerve Block Infusion KitI-Flow Corp. · 1999
- 4 generations backK020862 I-Flow Elastomeric PumpI-Flow Corp. · 2002 · Recalled
- 3 generations backK023098 Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser…Mckinley Infuser · 2002
- 2 generations backK033039 Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsMckinley, Inc. · 2003
- 1 generation backK042246 Multi-Drip Infusion CatheterAdvanced Infusion, Inc. · 2004
- This deviceK061356 Polyurethane Infusion Catheter, Alpha Cath, Model PAC20, and…Advanced Infusion, Inc. · 2006
Class I recalls in this family
- K993691 Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen…direct predicate · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| −7 | K980558 | Painbuster Infusion System | I-Flow Corp. | 1998 | — |
| −6 | K982946 | Painbuster Infusion Kit | I-Flow Corp. | 1998 | — |
| −5 | K984502 | Nerve Block Infusion Kit | I-Flow Corp. | 1999 | — |
| −4 | K020862 | I-Flow Elastomeric Pump | I-Flow Corp. | 2002 | 1 |
| −3 | K023098 | Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit | Mckinley Infuser | 2002 | — |
| −2 | K033039 | Modification to: Accufuser, Accufuser Plus, Standard Procedure Kits | Mckinley, Inc. | 2003 | — |
| −1 | K042246 | Multi-Drip Infusion Catheter | Advanced Infusion, Inc. | 2004 | — |
| 0 (this device) | K061356 | Polyurethane Infusion Catheter, Alpha Cath, Model PAC20, and Polyurethane… | Advanced Infusion, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 2 | 0 |
| 1995 | 2 | 0 |
| 1998 | 3 | 0 |
| 1999 | 6 | 0 |
| 2000 | 2 | 1 |
| 2001 | 3 | 0 |
| 2002 | 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.
1 device in this family has a Class I recall. 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 MED device
- #1 K251666 SYSTEM 1E Liquid Chemical Sterilant Processing…score 13.8 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021964 | Alpha Infusion Pump and CathetersSummary page 1…Classification Name: Catheter, Conduction, Anesthetic (21 CFR 868.5120, Product Code BSO) Predicate Devices: K021964- Alpha Infusion Pump and Catheters K042246 - Multi Drip Infusion Catheter… | 2002 |
| * | K042246 | Multi-Drip Infusion CatheterSummary page 1…(21 CFR 868.5120, Product Code BSO) Predicate Devices: K021964- Alpha Infusion Pump and Catheters K042246 - Multi Drip Infusion Catheter K003915 - Accufuser and Accufuser Plus… | 2004 |
| * | K003915 | Accufuser; Accufuser PlusSummary page 1…Devices: K021964- Alpha Infusion Pump and Catheters K042246 - Multi Drip Infusion Catheter K003915 - Accufuser and Accufuser Plus K993691 - ARROWg+ard Blue Plus Antimicrobial Multi Lumen… | 2001 |
| * | K993691 | Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterSummary page 1…K042246 - Multi Drip Infusion Catheter K003915 - Accufuser and Accufuser Plus K993691 - ARROWg+ard Blue Plus Antimicrobial Multi Lumen Catheter Device Description:… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K993691Arrowg +Ard Blue Plus Antimicrobial Multi-Lumen Central Venous CatheterArrow Intl., Inc. · 2000 · Direct predicate · ◆ in the 2000 ancestors bar of FIG. 11 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 11 months on median.
- 6 of the 31 ancestors have a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K021964.
How does its category compare?
All MED devicesMED Sterilant, Medical Devices: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MED
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · MED
84in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MED
2in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MED
9in 2025
MAUDE reports naming product code MED, 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 | 2 | — | 3 | 34 |
| 2008 | 1 | — | 2 | 79 |
| 2009 | 0 | — | 0 | 158 |
| 2010 | 6 | 281 | 0 | 89 |
| 2011 | 0 | — | 2 | 106 |
| 2012 | 3 | 111 | 0 | 337 |
| 2013 | 1 | — | 0 | 140 |
| 2014 | 1 | — | 0 | 105 |
| 2015 | 0 | — | 0 | 110 |
| 2016 | 1 | — | 0 | 135 |
| 2017 | 1 | — | 0 | 74 |
| 2018 | 2 | — | 0 | 42 |
| 2019 | 4 | 84 | 0 | 35 |
| 2020 | 0 | — | 0 | 32 |
| 2021 | 2 | — | 0 | 31 |
| 2022 | 1 | — | 0 | 16 |
| 2023 | 2 | — | 0 | 9 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Polyurethane Infusion Catheters are intended for use with the Alpha Infusion Pump for the infusion of a local anesthetic into a surgical site or body cavity, post-operatively, for the relief of pain. The Polyurethane Infusion Catheters are intended for use in the hospital or by an ambulatory patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061356 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061356: Polyurethane Infusion Catheter, Alpha Cath, Model PAC20, and Polyurethane Infusion Catheter, Multi Drip, Model PMD20-6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061356
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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