510(k) · Cleared
Recalled · 2008Auto Syringe (R) AS50 Infusion Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · FRN Pump, Infusion
Cleared on Jul 10, 1995 after a 217-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 of the 25 devices in its family, counting itself, have a Class I recall. 24 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 10, 1995
- Review
- 217 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 3
- Predicates
- 0
24 later devices descend from it, 1 citing it directly. 7 of the 25 devices in this family, counting this one, have a Class I recall.
- This deviceK945942 Auto Syringe (R) AS50 Infusion PumpBaxter Healthcare Corp · 1995
- Descendant · cites it directly · 23 of its ownK982640 Medex 3000 Series Syringe Infusion PumpMedex, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 21 of its ownK023264 Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · Recalled (Class I)
- Descendant · 3 generations on · 6 of its ownK053554 CompufloMilestone Scientific, Inc. · 2006
- Descendant · 4 generations on · 5 of its ownK101194 Navigator Delivery System (or Navigator DS) Model: Nav-010Carticept Medical, Inc. · 2011
- Descendant · 5 generations on · 4 of its ownK112067 Navigator Delivery System (Navigator DS)Carticept Medical, Inc. · 2011
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 24 · See all- K982640Medex 3000 Series Syringe Infusion PumpMedex, Inc. · 1999 · cites it directly23descendants
- K023264Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · 2 generations on21descendants
- K053554CompufloMilestone Scientific, Inc. · 2006 · 3 generations on6descendants
- K101194Navigator Delivery System (or Navigator DS) Model: Nav-010Carticept Medical, Inc. · 2011 · 4 generations on5descendants
- K112067Navigator Delivery System (Navigator DS)Carticept Medical, Inc. · 2011 · 5 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K945942 | Auto Syringe (R) AS50 Infusion Pump | Baxter Healthcare Corp | 1995 | — |
| +1 | K982640 | Medex 3000 Series Syringe Infusion Pump | Medex, Inc. | 1999 | 1 |
| +2 | K023264 | Medley Syringe Pump Module System, Model 8110 | Alaris Medical Systems, Inc. | 2002 | Class I |
| +3 | K053554 | Compuflo | Milestone Scientific, Inc. | 2006 | — |
| +4 | K101194 | Navigator Delivery System (or Navigator DS) Model: Nav-010 | Carticept Medical, Inc. | 2011 | — |
| +5 | K112067 | Navigator Delivery System (Navigator DS) | Carticept Medical, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 1 | 1 |
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 3 | 1 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 1 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 1 |
| 2022 | 2 | 1 |
| 2023 | 1 | 1 |
| 2024 | 1 | 1 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
7 devices in this family have a Class I recall. 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 FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (24)
See all 241 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982640 | Medex 3000 Series Syringe Infusion Pump | 1999 | 23 |
Has anything in its family been recalled? (7 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 5, 2008 | Not classified | Z-0152-2009 | Nonconforming Material/Component | Non-conforming Electrostatic Discharge (ESD) grounding squares may cause the pump to be susceptible to shorting-out of circuitry, resulting in a loss of audio, and/or interruption of therapy. |
| Feb 7, 2006 | Not classified | Z-0612-06 | Other | A non-conforming gasket was used in manufacturing of the specific pumps, causing the pumps to be more susceptible to electro-static discharge, which could increase the potential for the pump to fail during use and alarm. |
| May 6, 2005 | Not classified | Z-0159-06 | Other | A 'Check Flange' alarm may occur even though the syringe has been properly loaded into the AS50 Infusion Pump. The false alarm may occur during the syringe loading process or while an infusion is running. Also, the occlusion detection and… |
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K023264Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · 2 generations on · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
- K133532Alaris System with Guardrails Suite MXCarefusion 303, Inc. · 2014 · 3 generations on · ◆ in the 2014 descendants bar of FIG. 128 Class I recalls
- K111386Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety Software and Supported…Smiths Medical MD, Inc. · 2011 · 3 generations on · ◆ in the 2011 descendants bar of FIG. 16 Class I recalls
- K191910SpaceStation MRIB. Braun Melsugen AG · 2020 · 4 generations on · ◆ in the 2020 descendants bar of FIG. 13 Class I recalls
- K211125Novum IQ Syringe PumpBaxter Healthcare Corporation · 2022 · 4 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
- K211218BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc. · 2023 · 4 generations on · ◆ in the 2023 descendants bar of FIG. 17 Class I recalls
- K242390Novum IQ Syringe Pump (40800BAXUS)Baxter Healthcare Corporation · 2024 · 5 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
Nearest 5 of 7; all are on the web page.
What does this lineage say?
- Of its descendants, K982640 (Medex, Inc., 1999) has gone furthest, with 23 descendants of its own.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, 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 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
https://510kreport.com/device/K945942 · printed Nov 4, 2026
Cite this page
510(k) Report. “K945942: Auto Syringe (R) AS50 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/K945942
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026