510(k) · Cleared
ClearedAlpha Infusion Pump, Model A200, A450
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 Feb 19, 2008 as substantially equivalent to K021964 (Advanced Infusion, Inc., 2002) and 1 other predicate after a 259-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Feb 19, 2008
- Review
- 259 days
- Class
- Class II
- Product code
- MEB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K896422 (1990). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 3 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
- 2 generations backK992551 Alpha Infusion PumpAdvanced Infusion, Inc. · 1999
- 1 generation backK021964 Alpha Infusion Pump and CathetersAdvanced Infusion, Inc. · 2002
- This deviceK071532 Alpha Infusion Pump, Model A200, A450Advanced Infusion, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| −3 | K980558 | Painbuster Infusion System | I-Flow Corp. | 1998 | — |
| −2 | K992551 | Alpha Infusion Pump | Advanced Infusion, Inc. | 1999 | — |
| −1 | K021964 | Alpha Infusion Pump and Catheters | Advanced Infusion, Inc. | 2002 | — |
| 0 (this device) | K071532 | Alpha Infusion Pump, Model A200, A450 | Advanced Infusion, Inc. | 2008 | — |
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 |
| 2001 | 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? (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 |
|---|---|---|---|
| * | K021964 | Alpha Infusion Pump and CathetersSummary page 1…Classification Name: Elastomeric Infusion Pump (21 CFR 880.5725, Product Code MEB) Predicate Devices: K021964 - Alpha Infusion Pump and Catheters KO03915 - Accufuser and AccaLfuser Plus Device… | 2002 |
| * | K003915 | Accufuser; Accufuser Plus | 2001 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- 1 of the 11 ancestors has a recall of any class.
- 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. 2008, this device’s year, is highlighted.
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 is intended for the infusion of a local anesthetic into a surgical site or body cavity, post-operatively, for the relief of pain. Medication is intended to be delivered through a catheter containing a flow restriction element. The Alpha Infusion Pump is intended for use in the hospital or by an ambulatory patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071532 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071532: Alpha Infusion Pump, Model A200, A450.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071532
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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