510(k) · Cleared
Recalled · Class II · 2017Stat 2 IV Pumpette
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Master Medical Corp. · LDR Controller, Infusion, Intravascular, Electronic
Cleared on Apr 16, 1991 after a 130-day review. FDA has not posted a summary or statement for it, so its predicates are not known. It has been recalled 5 times.
- Decided
- Apr 16, 1991
- Review
- 130 days
- Class
- Class II
- Product code
- LDR
- Recalls
- 5
- Predicates
- 0
FDA has not posted a summary or statement for it, so its predicates are not known.
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.
Planning a device in LDR? 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 LDR device
- #1 K232316 DEKA Infusion System, DEKA Administration Setscore 10.5 · 3 generations · no Class I recall
- #2 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?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 19, 2017 | Class II | Z-0804-2018 | Nonconforming Material/Component | Intravascular (I.V.) fluid administration sets are exhibiting inaccurate or inconsistent flow rates. |
| Apr 15, 2011 | Not classified | Z-0629-2012 | Mixed-up of materials/components | ConMed received complaints of some units exhibiting inaccurate or inconsistent flow rates. It was determined that certain units were assembled with an incorrect component which could result in the devices exhibiting a different flow rate… |
| Apr 15, 2011 | Not classified | Z-0634-2012 | Mixed-up of materials/components | ConMed received complaints of some units exhibiting inaccurate or inconsistent flow rates. It was determined that certain units were assembled with an incorrect component which could result in the devices exhibiting a different flow rate… |
| Apr 15, 2011 | Not classified | Z-0683-2012 | Device Design | ConMed received 16 complaints for STAT 2 Pumpette devices for inaccurate flow rates and for leakage from the body of the compensating controller. The investigation of the complaints determined that the STAT 2 Pumpette Compensating… |
| Apr 15, 2011 | Not classified | Z-0682-2012 | Device Design | ConMed received 16 complaints for STAT 2 Pumpette devices for inaccurate flow rates and for leakage from the body of the compensating controller. The investigation of the complaints determined that the STAT 2 Pumpette Compensating… |
No ancestor or descendant has a Class I recall.
How does its category compare?
All LDR devicesLDR Controller, Infusion, Intravascular, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LDR
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LDR
Too few LDR 510(k)s in any year since 2007 to give a median.
Recalls per year · LDR
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LDR
3in 2023
MAUDE reports naming product code LDR, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 4 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 0 | — | 0 | 22 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K905498 · printed Nov 6, 2026
Cite this page
510(k) Report. “K905498: Stat 2 IV Pumpette.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K905498
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Record history
- FDA decision record loaded May 2, 2026
- Page last updated Nov 3, 2026