510(k) · Cleared
ClearedAlpha Infusion Pump and Catheters
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 12, 2002 as substantially equivalent to K992551 (Advanced Infusion, Inc., 1999) after a 59-day review. Its family tree reaches back 3 generations to 1990. 4 later devices descend from it.
- Decided
- Aug 12, 2002
- Review
- 59 days
- Class
- Class II
- Product code
- MEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K896422 (1990). 9 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 2 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
- 1 generation backK992551 Alpha Infusion PumpAdvanced Infusion, Inc. · 1999
- This deviceK021964 Alpha Infusion Pump and CathetersAdvanced Infusion, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK042246 Multi-Drip Infusion CatheterAdvanced Infusion, Inc. · 2004
- Descendant · cites it directly · 0 of its ownK071532 Alpha Infusion Pump, Model A200, A450Advanced Infusion, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK061661 Sta Cath Attachable Infision Catheter, Model STA20Advanced Infusion, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK061356 Polyurethane Infusion Catheter, Alpha Cath, Model PAC20, and…Advanced Infusion, Inc. · 2006
Most influential descendants
Showing 4 of 4 · See all- K042246Multi-Drip Infusion CatheterAdvanced Infusion, Inc. · 2004 · cites it directly1descendant
- K071532Alpha Infusion Pump, Model A200, A450Advanced Infusion, Inc. · 2008 · cites it directly0descendants
- K061661Sta Cath Attachable Infision Catheter, Model STA20Advanced Infusion, Inc. · 2006 · cites it directly0descendants
- 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 |
|---|---|---|---|---|---|
| −3 | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| −2 | K980558 | Painbuster Infusion System | I-Flow Corp. | 1998 | — |
| −1 | K992551 | Alpha Infusion Pump | Advanced Infusion, Inc. | 1999 | — |
| 0 (this device) | K021964 | Alpha Infusion Pump and Catheters | Advanced Infusion, Inc. | 2002 | — |
| +1 | K042246 | Multi-Drip Infusion Catheter | Advanced Infusion, Inc. | 2004 | — |
| +1 | K071532 | Alpha Infusion Pump, Model A200, A450 | Advanced Infusion, Inc. | 2008 | — |
| +1 | K061661 | Sta Cath Attachable Infision Catheter, Model STA20 | Advanced Infusion, Inc. | 2006 | — |
| +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 |
|---|---|---|
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 2 | 0 |
| 2008 | 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? (1)
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 |
|---|---|---|---|
| * | K992551 | Alpha Infusion PumpSummary page 1…aims substantial cquivalcnce in idended use and is similar in design, construction, and operation to the cumntly marketed Alpha Inkion Pump and Cathders (IC992551)- 4. Description of bevice: The Alpba Infusion Purnp is comprised of dual elastomeric chambers which hold the fluid… | 1999 |
What descends from it? (4)
4 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)
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 12 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K042246 (Advanced Infusion, Inc., 2004) has gone furthest, with 1 descendant of its own.
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 Alpha Infusion Pump and associated Catheters are intended for intravenous, intra-arterial, subcutaneous, or epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates. Medications or fluids are intended to be delivered through a catheter containing a flow restriction element.
The Alpha Infusion Pump and associated Catheters are suitable for use as an ambulatory device and are intended for use in the home environment but not limited to use in the home environment
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/K021964 · printed Nov 6, 2026
Cite this page
510(k) Report. “K021964: Alpha Infusion Pump and Catheters.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K021964
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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