510(k) · Cleared
ClearedParagon Basal/Bolus Administration Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I-Flow Corp. · FPA Set, Administration, Intravascular
Cleared on Feb 9, 1999 as substantially equivalent to K923875 (I-Flow Corp., 1993) and 4 other predicates after an 85-day review. Its family tree reaches back 3 generations to 1990. 1 of the 16 devices in its family, counting itself, has a Class I recall. 9 later devices descend from it.
- Decided
- Feb 9, 1999
- Review
- 85 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K896422 (1990). 6 ancestors in all. 9 later devices descend from it, 1 citing it directly. 1 of the 16 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 2 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
- 1 generation backK982946 Painbuster Infusion KitI-Flow Corp. · 1998
- This deviceK984063 Paragon Basal/Bolus Administration SetI-Flow Corp. · 1999
- Descendant · cites it directly · 8 of its ownK020251 Paragon Infusion SystemI-Flow Corp. · 2002
- Descendant · 2 generations on · 5 of its ownK052451 MPS Acacia Medflo Elastomeric PumpMps Acacia · 2005
- Descendant · 3 generations on · 4 of its ownK081905 Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · Recalled (Class I)
- Descendant · 4 generations on · 3 of its ownK151650 SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016
- Descendant · 5 generations on · 0 of its ownK250234 SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd. · 2026
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K081905 Accuflow and Accuflux Elastomeric Infusion Pump3 generations on · 2008
Most influential descendants
Showing 5 of 9 · See all- K020251Paragon Infusion SystemI-Flow Corp. · 2002 · cites it directly8descendants
- K052451MPS Acacia Medflo Elastomeric PumpMps Acacia · 2005 · 2 generations on5descendants
- K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · 3 generations on4descendants
- K151650SMARTez elastomeric infusion pumpEpic Medical Pte., Ltd. · 2016 · 4 generations on3descendants
- K250234SMARTeZ™ Elastomeric Infusion Pump (RS series)Epic Medical Pte., Ltd. · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| −2 | K980558 | Painbuster Infusion System | I-Flow Corp. | 1998 | — |
| −1 | K982946 | Painbuster Infusion Kit | I-Flow Corp. | 1998 | — |
| 0 (this device) | K984063 | Paragon Basal/Bolus Administration Set | I-Flow Corp. | 1999 | — |
| +1 | K020251 | Paragon Infusion System | I-Flow Corp. | 2002 | — |
| +2 | K052451 | MPS Acacia Medflo Elastomeric Pump | Mps Acacia | 2005 | — |
| +3 | K081905 | Accuflow and Accuflux Elastomeric Infusion Pump | Westmed, Inc. | 2008 | Class I |
| +4 | K151650 | SMARTez elastomeric infusion pump | Epic Medical Pte., Ltd. | 2016 | — |
| +5 | K250234 | SMARTeZ™ Elastomeric Infusion Pump (RS series) | Epic Medical Pte., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 1 |
| 2016 | 1 | 0 |
| 2024 | 2 | 0 |
| 2026 | 1 | 0 |
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.
1 device in this family has 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 FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 2…s submission is intended to notify the Federal Food and Drug Administration that I-Flow Corporation intends to market a new intended use for the Paragon Infusion System (K923875), originally identified as the SideKick 50 Plus and SideKick 100 Plus. The Paragon will be marketed as a kit, the Paragon Infusio… | 1993 |
| * | K980558 | Painbuster Infusion SystemSummary page 2…on set are the same as used in K923875. The Paragon Kit is substantially equivalent to the I-Flow Paragon Infusion System (K923875), the I-Flow PainBuster Infusion Kit (K980558, K982946), the Sgarlato Pain Control Infusion Pump (PCIP) (K896422) and the |-Flow Homepump C-Series (K944692). 2.0 PHYSICAL SPE… | 1998 |
| * | K982946 | Painbuster Infusion Kit Cleared while this submission was under review Summary page 2…e the same as used in K923875. The Paragon Kit is substantially equivalent to the I-Flow Paragon Infusion System (K923875), the I-Flow PainBuster Infusion Kit (K980558, K982946), the Sgarlato Pain Control Infusion Pump (PCIP) (K896422) and the |-Flow Homepump C-Series (K944692). 2.0 PHYSICAL SPECIFICATIO… | 1998 |
| * | K896422 | Burron Ambulatory Drug Delivery SystemSummary page 2…tially equivalent to the I-Flow Paragon Infusion System (K923875), the I-Flow PainBuster Infusion Kit (K980558, K982946), the Sgarlato Pain Control Infusion Pump (PCIP) (K896422) and the |-Flow Homepump C-Series (K944692). 2.0 PHYSICAL SPECIFICATIONS AND DESCRIPTIONS 2.1 Description of the Paragon Infusio… | 1990 |
| * | K944692 | C-Series HomepumpSummary page 2…usion System (K923875), the I-Flow PainBuster Infusion Kit (K980558, K982946), the Sgarlato Pain Control Infusion Pump (PCIP) (K896422) and the |-Flow Homepump C-Series (K944692). 2.0 PHYSICAL SPECIFICATIONS AND DESCRIPTIONS 2.1 Description of the Paragon Infusion Kit 2.1.1 212 2.1.3 214 2.1.5 The P… | 1995 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020251 | Paragon Infusion System | 2002 | 8 |
Has anything in its family been recalled? (1 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.
- K081905Accuflow and Accuflux Elastomeric Infusion PumpWestmed, Inc. · 2008 · 3 generations on · ◆ in the 2008 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 6 months on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K020251 (I-Flow Corp., 2002) has gone furthest, with 8 descendants of its own.
- 5 other devices also cite its predicate K923875.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, 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 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
The Paragon Basal/Bolus Administration Set is intended to provide a continuous, basal level infusion of medication and to allow patient controlled bolus delivery. The bolus component of the administration set enables fixed boluses of medication to be delivered upon demand by the patient or healthcare provider. The Paragon Basal/Bolus Administration Set routes of administration include: intravenous, epidural, intramuscular and subcutaneous.
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/K984063 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984063: Paragon Basal/Bolus Administration Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984063
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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