510(k) · Cleared
ClearedAlpha Infusion Pump
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 Oct 27, 1999 as substantially equivalent to K922382 (Baxter Healthcare Corp, 1993) and 5 other predicates after an 89-day review. Its family tree reaches back 2 generations to 1990. 5 later devices descend from it.
- Decided
- Oct 27, 1999
- Review
- 89 days
- Class
- Class II
- Product code
- MEB
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 2 generations to K896422 (1990). 8 ancestors in all. 5 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 1 generation backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
- This deviceK992551 Alpha Infusion PumpAdvanced Infusion, Inc. · 1999
- Descendant · cites it directly · 4 of its ownK021964 Alpha Infusion Pump and CathetersAdvanced Infusion, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK042246 Multi-Drip Infusion CatheterAdvanced Infusion, Inc. · 2004
- Descendant · 2 generations on · 0 of its ownK071532 Alpha Infusion Pump, Model A200, A450Advanced Infusion, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK061661 Sta Cath Attachable Infision Catheter, Model STA20Advanced Infusion, Inc. · 2006
- Descendant · 2 generations on · 0 of its ownK061356 Polyurethane Infusion Catheter, Alpha Cath, Model PAC20, and…Advanced Infusion, Inc. · 2006
Most influential descendants
Showing 5 of 5 · See all- K021964Alpha Infusion Pump and CathetersAdvanced Infusion, Inc. · 2002 · cites it directly4descendants
- K042246Multi-Drip Infusion CatheterAdvanced Infusion, Inc. · 2004 · 2 generations on1descendant
- K071532Alpha Infusion Pump, Model A200, A450Advanced Infusion, Inc. · 2008 · 2 generations on0descendants
- K061661Sta Cath Attachable Infision Catheter, Model STA20Advanced Infusion, Inc. · 2006 · 2 generations on0descendants
- K061356Polyurethane Infusion Catheter, Alpha Cath, Model PAC20, and Polyurethane Infusion…Advanced Infusion, Inc. · 2006 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| −1 | K980558 | Painbuster Infusion System | I-Flow Corp. | 1998 | — |
| 0 (this device) | K992551 | Alpha Infusion Pump | Advanced Infusion, Inc. | 1999 | — |
| +1 | K021964 | Alpha Infusion Pump and Catheters | Advanced Infusion, Inc. | 2002 | — |
| +2 | K042246 | Multi-Drip Infusion Catheter | Advanced Infusion, Inc. | 2004 | — |
| +2 | K071532 | Alpha Infusion Pump, Model A200, A450 | Advanced Infusion, Inc. | 2008 | — |
| +2 | K061661 | Sta Cath Attachable Infision Catheter, Model STA20 | Advanced Infusion, Inc. | 2006 | — |
| +2 | 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 |
|---|---|---|
| 2002 | 1 | 0 |
| 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? (6)
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 |
|---|---|---|---|
| * | K922382 | Intermate (R) LV Elastomeric Infusion DeviceSummary page 2…Pump The propased device, the Alpha Infision Pump, claims substantial equivalence in intended use and operation to the Baxter Intermate LV Elastomeric Infusion Device (K922382) and the I-Flow PainBuster Infusion System (K980558). Both are elastomeric chamber infusion pump intended to deliver medications… | 1993 |
| * | K980558 | Painbuster Infusion SystemSummary page 2…claims substantial equivalence in intended use and operation to the Baxter Intermate LV Elastomeric Infusion Device (K922382) and the I-Flow PainBuster Infusion System (K980558). Both are elastomeric chamber infusion pump intended to deliver medications or fluids to a patient by an intravenous, intra-arte… | 1998 |
| * | K896422 | Burron Ambulatory Drug Delivery SystemSummary page 2…ate using a flow restrictor. The proposed device, the Alpha Infusion Pump, claims substantial equivalence in intended use to the Burron Ambulatory Drug Delivery System (K896422), the Sgarlato Laboratories Pain Contro! Infusion Pump (K990101), and the McKinley Medical OutBound Disposable Syringe Infusor (K… | 1990 |
| * | K990101 | Pain Control Infusion PumpSummary page 2…usion Pump, claims substantial equivalence in intended use to the Burron Ambulatory Drug Delivery System (K896422), the Sgarlato Laboratories Pain Contro! Infusion Pump (K990101), and the McKinley Medical OutBound Disposable Syringe Infusor (K982256). These infusion pumps differ from the Alpha Infusion Pum… | 1999 |
| * | K982256 | Outbound Disposable Syringe Infuser Outbound 2 Disposable PumpSummary page 2…Ambulatory Drug Delivery System (K896422), the Sgarlato Laboratories Pain Contro! Infusion Pump (K990101), and the McKinley Medical OutBound Disposable Syringe Infusor (K982256). These infusion pumps differ from the Alpha Infusion Pump only in the method used to pressurize the medication or fluid containe… | 1998 |
| * | K983454 | Pain Care 2000Summary page 2…he Alpha Infusion Pump, claims substantial equivalence in intended use to the McKinley Medical OutBound PCA Pain Management System (K982256) and the Breg Pain Care 2000 (K983454). These infusion systems provide for the delivery of a bolus of medication on patient demand through a percutaneous catheter. ==… | 1998 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K021964 | Alpha Infusion Pump and Catheters | 2002 | 4 |
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 9 years and passes through 3 companies; a new generation was cleared every 8.1 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K021964 (Advanced Infusion, Inc., 2002) has gone furthest, with 4 descendants 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 is 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
percutaneously through a catheter.
The Alpha Infusion Pump is suitable for usc as an ambulatory device and is
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/K992551 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992551: Alpha Infusion Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992551
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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