510(k) · Cleared
ClearedMulti-Drip Infusion Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Infusion, Inc. · MEB Pump, Infusion, Elastomeric
Cleared on Aug 31, 2004 as substantially equivalent to K021964 (Advanced Infusion, Inc., 2002) and 2 other predicates after a 12-day review. Its family tree reaches back 7 generations to 1990. 1 later device descends from it.
- Decided
- Aug 31, 2004
- Review
- 12 days
- Class
- Class II
- Product code
- MEB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K896422 (1990). 28 ancestors in all, the oldest K813186 (1981). 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 6 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
- 5 generations backK982946 Painbuster Infusion KitI-Flow Corp. · 1998
- 4 generations backK984502 Nerve Block Infusion KitI-Flow Corp. · 1999
- 3 generations backK020862 I-Flow Elastomeric PumpI-Flow Corp. · 2002 · Recalled
- 2 generations backK023098 Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser…Mckinley Infuser · 2002
- 1 generation backK033039 Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsMckinley, Inc. · 2003
- This deviceK042246 Multi-Drip Infusion CatheterAdvanced Infusion, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK061356 Polyurethane Infusion Catheter, Alpha Cath, Model PAC20, and…Advanced Infusion, Inc. · 2006
Most influential descendants
Showing 1 of 1 · See all- K061356Polyurethane Infusion Catheter, Alpha Cath, Model PAC20, and Polyurethane Infusion…Advanced Infusion, Inc. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| −6 | K980558 | Painbuster Infusion System | I-Flow Corp. | 1998 | — |
| −5 | K982946 | Painbuster Infusion Kit | I-Flow Corp. | 1998 | — |
| −4 | K984502 | Nerve Block Infusion Kit | I-Flow Corp. | 1999 | — |
| −3 | K020862 | I-Flow Elastomeric Pump | I-Flow Corp. | 2002 | 1 |
| −2 | K023098 | Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit | Mckinley Infuser | 2002 | — |
| −1 | K033039 | Modification to: Accufuser, Accufuser Plus, Standard Procedure Kits | Mckinley, Inc. | 2003 | — |
| 0 (this device) | K042246 | Multi-Drip Infusion Catheter | Advanced Infusion, Inc. | 2004 | — |
| +1 | 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 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 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 MEB? 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 MEB device
- #1 K250234 SMARTeZ™ Elastomeric Infusion Pump (RS series)score 14.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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…ce: The proposed device, the Multi Driptm Infusion Catheter, claims substantial equivalence to Al's currently marketed Alpha Cathi Infusion Catheter (K021964) in function, design, materials of construction, operation, and intended use. Both catheters are for use with the… | 2002 |
| * | K994374 | Soaker CatheterSummary page 1…nfusion Pump (K02 1964). In addition, the Multi Drip"' Infusion Catheter claims substantial equivalence to the I-Flow Soaker multiple port Catheter (K994374) and the Stryker (McKinley) ExFen multiple port Catheter (K033039) in regards to the function, overall design of the di… | 2000 |
| * | K033039 | Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsSummary page 1…atheter claims substantial equivalence to the I-Flow Soaker multiple port Catheter (K994374) and the Stryker (McKinley) ExFen multiple port Catheter (K033039) in regards to the function, overall design of the distal end of the catheter, and intended use. 4. Description of Dev… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061356 | Polyurethane Infusion Catheter, Alpha Cath, Model PAC20, and Polyurethane Infusion… | 2006 | 0 |
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 14 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 5 of the 28 ancestors have a recall of any class.
- Of its descendants, K061356 (Advanced Infusion, Inc., 2006) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K021964.
How does its category compare?
All MEB devicesMEB Pump, Infusion, Elastomeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEB
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MEB
42in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEB
17in 2018
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · MEB
1,408in 2025
MAUDE reports naming product code MEB, 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 | 5 | 42 | 1 | 110 |
| 2008 | 2 | — | 3 | 444 |
| 2009 | 1 | — | 48 | 798 |
| 2010 | 0 | — | 2 | 1,827 |
| 2011 | 0 | — | 8 (1) | 2,265 |
| 2012 | 0 | — | 0 | 1,976 |
| 2013 | 1 | — | 2 (1) | 1,956 |
| 2014 | 1 | — | 0 | 2,695 |
| 2015 | 0 | — | 0 | 2,980 |
| 2016 | 1 | — | 0 | 2,147 |
| 2017 | 0 | — | 0 | 1,653 |
| 2018 | 0 | — | 17 | 1,473 |
| 2019 | 1 | — | 0 | 974 |
| 2020 | 0 | — | 0 | 2,732 |
| 2021 | 0 | — | 0 | 1,802 |
| 2022 | 0 | — | 0 | 1,288 |
| 2023 | 0 | — | 0 | 1,248 |
| 2024 | 2 | — | 0 | 1,424 |
| 2025 | 0 | — | 0 | 1,408 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Multi Drip Infusion Catheter is a single-use, short duration catheter intended for use with the Alpha Infusion Pump for the continuous infusion of medication directly into an intraoperative site for postoperative pain management. Infusions may also be administered percutaneously.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042246 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042246: Multi-Drip Infusion Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042246
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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