510(k) · Cleared
ClearedPharmguard Toolbox, Model G6000782
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medex, Inc. · FRN Pump, Infusion
Cleared on Jan 4, 2005 after a 118-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 of the 6 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.
- Decided
- Jan 4, 2005
- Review
- 118 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly. 3 of the 6 devices in this family, counting this one, have a Class I recall.
- This deviceK042432 Pharmguard Toolbox, Model G6000782Medex, Inc. · 2005
- Descendant · cites it directly · 4 of its ownK111386 Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2…Smiths Medical MD, Inc. · 2011 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK211125 Novum IQ Syringe PumpBaxter Healthcare Corporation · 2022 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK160482 t:slim Insulin Delivery System, t:flex Insulin Delivery System…Tandem Diabetes Care, Inc. · 2016
- Descendant · 3 generations on · 0 of its ownK242390 Novum IQ Syringe Pump (40800BAXUS)Baxter Healthcare Corporation · 2024 · Recalled (Class I)
- Descendant · 3 generations on · 0 of its ownK162080 t:slim Insulin Delivery System, t:flex Insulin Delivery System…Tandem Diabetes Care, Inc. · 2016
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K111386Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety…Smiths Medical MD, Inc. · 2011 · cites it directly4descendants
- K211125Novum IQ Syringe PumpBaxter Healthcare Corporation · 2022 · 2 generations on1descendant
- K160482t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc. · 2016 · 2 generations on1descendant
- K242390Novum IQ Syringe Pump (40800BAXUS)Baxter Healthcare Corporation · 2024 · 3 generations on0descendants
- K162080t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc. · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042432 | Pharmguard Toolbox, Model G6000782 | Medex, Inc. | 2005 | — |
| +1 | K111386 | Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication… | Smiths Medical MD, Inc. | 2011 | Class I |
| +2 | K211125 | Novum IQ Syringe Pump | Baxter Healthcare Corporation | 2022 | Class I |
| +2 | K160482 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device… | Tandem Diabetes Care, Inc. | 2016 | — |
| +3 | K242390 | Novum IQ Syringe Pump (40800BAXUS) | Baxter Healthcare Corporation | 2024 | Class I |
| +3 | K162080 | t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device… | Tandem Diabetes Care, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 1 |
| 2016 | 2 | 0 |
| 2022 | 1 | 1 |
| 2024 | 1 | 1 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
3 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’s file for it is a 510(k) statement, which names no predicate.
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 |
|---|---|---|---|
| K111386 | Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety… Class I | 2011 | 4 |
Has anything in its family been recalled? (3 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.
- K111386Medfusion Model 4000 Syringe Infusion Pump, Pharmguard Toolbox 2 Medication Safety Software and Supported…Smiths Medical MD, Inc. · 2011 · Cites it directly · ◆ in the 2011 descendants bar of FIG. 16 Class I recalls
- K211125Novum IQ Syringe PumpBaxter Healthcare Corporation · 2022 · 2 generations on · ◆ in the 2022 descendants bar of FIG. 11 Class I recall
- K242390Novum IQ Syringe Pump (40800BAXUS)Baxter Healthcare Corporation · 2024 · 3 generations on · ◆ in the 2024 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K111386 (Smiths Medical MD, Inc., 2011) has gone furthest, with 4 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?
PharmGuard Toolbox is intended to provide a vehicle to create and securely upload user-defined configuration parameters, a library of drug names and associated user-defined infusion parameters to Medex Infusion Pumps. The PharmGuard Toolbox collects and downloads operational, infusion, and alarm history events, library usage counts, and PharmGuard safety events from compatible Medex Infusion Pumps. It is intended to provide a rich dataset users can collect and analyze to improve overall processes and lessen the likelihood of operator error when entering infusion parameters into the Medex Infusion Pumps.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K042432 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042432: Pharmguard Toolbox, Model G6000782.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042432
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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