510(k) · Cleared
ClearedPiv System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Solutions, Inc. · LDQ (no longer in FDA’s product-code list)
Cleared on Sep 2, 1998 after a 167-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 2, 1998
- Review
- 167 days
- Product code
- LDQ
- 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 LDQ? 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.
What is it indicated for?
The Medical Solutions PIV IV Bag Warmer and Pressure Infusor is designed to hold and heat IV fluid bags and maintain temperatures to 98° F ( 3°F). It is also a pressure infusor designed to be inflated to increase pressure on the IV bag to assist the infusion of fluid.
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/K981032 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981032: Piv System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981032
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026