510(k) · Cleared
ClearedSolopak Paragon Infusor Pump and Infusion Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solopak Medical Products, Inc. · MEB Pump, Infusion, Elastomeric
Cleared on Oct 4, 1996 as substantially equivalent to K923875 (I-Flow Corp., 1993) after a 39-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Oct 4, 1996
- Review
- 39 days
- Class
- Class II
- Product code
- MEB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K923875 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK923875 Sidekick 50 Plus and Sidekick 100 PlusI-Flow Corp. · 1993 · Recalled
- This deviceK963355 Solopak Paragon Infusor Pump and Infusion SetSolopak Medical Products, Inc. · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923875 | Sidekick 50 Plus and Sidekick 100 Plus | I-Flow Corp. | 1993 | 1 |
| 0 (this device) | K963355 | Solopak Paragon Infusor Pump and Infusion Set | Solopak Medical Products, Inc. | 1996 | — |
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.
Planning a device in MEB? 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 MEB device
- #1 K250234 SMARTeZ™ Elastomeric Infusion Pump (RS series)score 14.5 · 12 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 |
|---|---|---|---|
| * | K923875 | Sidekick 50 Plus and Sidekick 100 PlusSummary page 1…pump and administration set system are substantially equivalent to the Sidekick Plus Infusion Pump and Administration Sets legally marketed by I-Flow Corporation under K#923875. Substantial equivalence can be claimed by SoloPak Medical Products for the Paragon Infusion Pump and Administration Sets because… | 1993 |
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 does this lineage say?
- Its one ancestor has a recall.
- 5 other devices also cite its predicate K923875.
How does its category compare?
All MEB devicesMEB Pump, Infusion, Elastomeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEB
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MEB
42in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEB
17in 2018
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · MEB
1,408in 2025
MAUDE reports naming product code MEB, 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 | 5 | 42 | 1 | 110 |
| 2008 | 2 | — | 3 | 444 |
| 2009 | 1 | — | 48 | 798 |
| 2010 | 0 | — | 2 | 1,827 |
| 2011 | 0 | — | 8 (1) | 2,265 |
| 2012 | 0 | — | 0 | 1,976 |
| 2013 | 1 | — | 2 (1) | 1,956 |
| 2014 | 1 | — | 0 | 2,695 |
| 2015 | 0 | — | 0 | 2,980 |
| 2016 | 1 | — | 0 | 2,147 |
| 2017 | 0 | — | 0 | 1,653 |
| 2018 | 0 | — | 17 | 1,473 |
| 2019 | 1 | — | 0 | 974 |
| 2020 | 0 | — | 0 | 2,732 |
| 2021 | 0 | — | 0 | 1,802 |
| 2022 | 0 | — | 0 | 1,288 |
| 2023 | 0 | — | 0 | 1,248 |
| 2024 | 2 | — | 0 | 1,424 |
| 2025 | 0 | — | 0 | 1,408 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The SoloPak Medical Products, Paragon Infusion Pump and Administration Sets are intended to be used as a system for the purpose of delivering drugs and solutions through an in-dwelling catheter.
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/K963355 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963355: Solopak Paragon Infusor Pump and Infusion Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963355
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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