510(k) · Cleared
ClearedAutodose Infusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tandem Medical, Inc. · MEB Pump, Infusion, Elastomeric
Cleared on Jun 3, 1999 as substantially equivalent to K962663 (Solopak Medical Products, Inc., 1996) and 1 other predicate after a 78-day review. Its family tree reaches back 2 generations to 1992. 1 later device descends from it.
- Decided
- Jun 3, 1999
- Review
- 78 days
- Class
- Class II
- Product code
- MEB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K915646 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK915646 Vivus 50 and Vivus 100 Personal InfuserI-Flow Corp. · 1992
- 1 generation backK962663 Solopak Sidekick Infusion Pump and Administation SetSolopak Medical Products, Inc. · 1996
- This deviceK990889 Autodose Infusion SystemTandem Medical, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK993832 Autodose Infusion System, Model AD4120, BE4210, S12050,100,200…Tandem Medical, Inc. · 2000
Most influential descendants
Showing 1 of 1 · See all- K993832Autodose Infusion System, Model AD4120, BE4210, S12050,100,200, FF0005, 10Tandem Medical, Inc. · 2000 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K915646 | Vivus 50 and Vivus 100 Personal Infuser | I-Flow Corp. | 1992 | — |
| −1 | K962663 | Solopak Sidekick Infusion Pump and Administation Set | Solopak Medical Products, Inc. | 1996 | — |
| 0 (this device) | K990889 | Autodose Infusion System | Tandem Medical, Inc. | 1999 | — |
| +1 | K993832 | Autodose Infusion System, Model AD4120, BE4210, S12050,100,200, FF0005, 10 | Tandem Medical, Inc. | 2000 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 |
|---|---|---|---|
| * | K962663 | Solopak Sidekick Infusion Pump and Administation SetSummary page 1…on System b. Classification Name: Infusion Pump 21 CFR 880.5725 15.3 IDENTIFICATION OF PREDICATE DEVICES Company Device 510(k) No. Date Cleared Douglas SoloPak® Sidekick K962663 10/4/96 Medical Infusion Pump & Products Administration Set I-Flow Sidekick™ Infusion System K915646 6/15/92 CONFIDENTIAL 155… | 1996 |
| * | K915646 | Vivus 50 and Vivus 100 Personal InfuserSummary page 1…CES Company Device 510(k) No. Date Cleared Douglas SoloPak® Sidekick K962663 10/4/96 Medical Infusion Pump & Products Administration Set I-Flow Sidekick™ Infusion System K915646 6/15/92 CONFIDENTIAL 155 AutoDose Infusion System ORIGINAL PREMARKET 510(k) NOTIFICATION 154 DEVICE DESCRIPTI… | 1992 |
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 |
|---|---|---|---|
| K993832 | Autodose Infusion System, Model AD4120, BE4210, S12050,100,200, FF0005, 10 | 2000 | 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 7 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K993832 (Tandem Medical, Inc., 2000) has gone furthest, with 0 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 AutoDose Infusion System is intended for general use infusion of predetermined volumes of intravenous solutions.
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/K990889 · printed Nov 5, 2026
Cite this page
510(k) Report. “K990889: Autodose Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990889
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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