510(k) · Cleared
ClearedMsi Pressure Infusor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smith Assoc. · KZD Infusor, Pressure, For I.V. Bags
Cleared on Oct 29, 1997 after a 21-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 29, 1997
- Review
- 21 days
- Class
- Class I
- Product code
- KZD
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
Planning a device in KZD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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?
No later submission names this one as a predicate yet.
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.
How does its category compare?
All KZD devicesKZD Infusor, Pressure, For I.V. Bags: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KZD
FDA has decided no KZD device since 2007.
Median 510(k) review, days · KZD
Too few KZD 510(k)s in any year since 2007 to give a median.
Recalls per year · KZD
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KZD
41in 2025
MAUDE reports naming product code KZD, 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 | — | 11 | 3 |
| 2009 | 0 | — | 1 | 6 |
| 2010 | 0 | — | 0 | 9 |
| 2011 | 0 | — | 1 | 12 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 72 |
| 2015 | 0 | — | 0 | 31 |
| 2016 | 0 | — | 0 | 4 |
| 2017 | 0 | — | 0 | 38 |
| 2018 | 0 | — | 0 | 6 |
| 2019 | 0 | — | 0 | 4 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 13 |
| 2022 | 0 | — | 0 | 45 |
| 2023 | 0 | — | 0 | 31 |
| 2024 | 0 | — | 0 | 43 |
| 2025 | 0 | — | 0 | 41 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Medical Solutions, Inc.’s Reusable Pressure Infusor is a device consisting of an inflatable cuff which is placed around an I.V. bag. When the device is inflated, it increases the pressure on the I.V. bag to assist the infusion of fluid.
Caution: Federal (U.S.A) law restricts this device to sale by or on the order of a physician.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973843 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973843: Msi Pressure Infusor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973843
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026