510(k) · Cleared
ClearedVariable Pressure Syringe Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alaris Medical Systems, Inc. · FRN Pump, Infusion
Cleared on Dec 29, 1998 as substantially equivalent to K940147 (Baxter Corp., 1994) after a 406-day review. Its family tree reaches back 1 generation to 1994. 7 of the 24 devices in its family, counting itself, have a Class I recall. 22 later devices descend from it.
- Decided
- Dec 29, 1998
- Review
- 406 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K940147 (1994). 22 later devices descend from it, 1 citing it directly. 7 of the 24 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK940147 Auto Syringe AS40A Infusion PumpBaxter Corp. · 1994 · Recalled
- This deviceK974332 Variable Pressure Syringe PumpAlaris Medical Systems, Inc. · 1998
- Descendant · cites it directly · 21 of its ownK023264 Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · Recalled (Class I)
- Descendant · 2 generations on · 6 of its ownK053554 CompufloMilestone Scientific, Inc. · 2006
- Descendant · 3 generations on · 5 of its ownK101194 Navigator Delivery System (or Navigator DS) Model: Nav-010Carticept Medical, Inc. · 2011
- Descendant · 4 generations on · 4 of its ownK112067 Navigator Delivery System (Navigator DS)Carticept Medical, Inc. · 2011
- Descendant · 2 generations on · 4 of its ownK111386 Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2…Smiths Medical MD, Inc. · 2011 · Recalled (Class I)
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 22 · See all- K023264Medley Syringe Pump Module System, Model 8110Alaris Medical Systems, Inc. · 2002 · cites it directly21descendants
- K053554CompufloMilestone Scientific, Inc. · 2006 · 2 generations on6descendants
- K101194Navigator Delivery System (or Navigator DS) Model: Nav-010Carticept Medical, Inc. · 2011 · 3 generations on5descendants
- K112067Navigator Delivery System (Navigator DS)Carticept Medical, Inc. · 2011 · 4 generations on4descendants
- K111386Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety…Smiths Medical MD, Inc. · 2011 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K940147 | Auto Syringe AS40A Infusion Pump | Baxter Corp. | 1994 | 1 |
| 0 (this device) | K974332 | Variable Pressure Syringe Pump | Alaris Medical Systems, Inc. | 1998 | — |
| +1 | K023264 | Medley Syringe Pump Module System, Model 8110 | Alaris Medical Systems, Inc. | 2002 | Class I |
| +2 | K053554 | Compuflo | Milestone Scientific, Inc. | 2006 | — |
| +3 | K101194 | Navigator Delivery System (or Navigator DS) Model: Nav-010 | Carticept Medical, Inc. | 2011 | — |
| +4 | K112067 | Navigator Delivery System (Navigator DS) | Carticept Medical, Inc. | 2011 | — |
| +2 | K111386 | Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication… | Smiths Medical MD, Inc. | 2011 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 1 |
| 2006 | 2 | 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), 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.
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? (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 |
|---|---|---|---|
| * | K940147 | Auto Syringe AS40A Infusion PumpSummary page 1…7 Proprietary Name: Variable Pressure Syringe Pump Common Name: Syringe Pump Classification Name: Infusion Pump Baxter Corporation, Auto Syringe AS40A Infusion Pump, K940147 The P7000 is a variable pressure syringe pump suitable for critical care applications.” This instrument functions with a range o… | 1994 |
What descends from it? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023264 | Medley Syringe Pump Module System, Model 8110 Class I | 2002 | 21 |
Has anything in its family been recalled? (7 Class I)
No FDA recall names this device.
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 · Cites it directly · ◆ in the 2002 descendants bar of FIG. 11 Class I recall
- K133532Alaris System with Guardrails Suite MXCarefusion 303, Inc. · 2014 · 2 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 · 2 generations on · ◆ in the 2011 descendants bar of FIG. 16 Class I recalls
- K191910SpaceStation MRIB. Braun Melsugen AG · 2020 · 3 generations on · ◆ in the 2020 descendants bar of FIG. 13 Class I recalls
- K211125Novum IQ Syringe PumpBaxter Healthcare Corporation · 2022 · 3 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 · 3 generations on · ◆ in the 2023 descendants bar of FIG. 17 Class I recalls
- K242390Novum IQ Syringe Pump (40800BAXUS)Baxter Healthcare Corporation · 2024 · 4 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?
- Its one ancestor has a recall.
- Of its descendants, K023264 (Alaris Medical Systems, Inc., 2002) has gone furthest, with 21 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) | — |
What is it indicated for?
The Model P7000 is intended to be used for intravenous administration of drugs, blood, and blood products. This device is also indicated for epidural applications. The final DFU will contain all necessary precautions and recommendations for safe epidural application. ALARIS Medical Systems’ policy is to not indicate specific drugs and/or fluids except in cases when a device is designed specifically or solely for a particular drug or fluid. Consistent…
Read the full statement (111 words)
The Model P7000 is intended to be used for intravenous administration of drugs, blood, and blood products. This device is also indicated for epidural applications. The final DFU will contain all necessary precautions and recommendations for safe epidural application.
ALARIS Medical Systems’ policy is to not indicate specific drugs and/or fluids except in cases when a device is designed specifically or solely for a particular drug or fluid. Consistent with this policy, we would contraindicate drugs and/or fluids as appropriate for the P7000. No such contraindications have been identified.
The specific purpose for the P7000 is to offer users a fully featured variable pressure syringe pump suitable for critical care applications.
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/K974332 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974332: Variable Pressure Syringe Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974332
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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