510(k) · Cleared
ClearedParagon Bolus Accessory 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 K884505 (Baxter Healthcare Corp, 1989) and 1 other predicate after a 40-day review. Its family tree reaches back 1 generation to 1989. 2 of the 27 devices in its family, counting itself, have a Class I recall. 24 later devices descend from it.
- Decided
- Feb 9, 1999
- Review
- 40 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K884505 (1989). 2 ancestors in all. 24 later devices descend from it, 2 citing it directly. 2 of the 27 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK884505 Basal/Bolus InfusorsBaxter Healthcare Corp · 1989 · Recalled
- This deviceK984638 Paragon Bolus Accessory SetI-Flow Corp. · 1999
- Descendant · cites it directly · 21 of its ownK992072 Bolus Accessory SetI-Flow Corp. · 1999
- Descendant · 2 generations on · 19 of its ownK020862 I-Flow Elastomeric PumpI-Flow Corp. · 2002 · Recalled
- Descendant · 3 generations on · 17 of its ownK023098 Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser…Mckinley Infuser · 2002
- Descendant · 4 generations on · 15 of its ownK033039 Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsMckinley, Inc. · 2003
- Descendant · 4 generations on · 8 of its ownK032642 Beeline SystemMckinley, Inc. · 2003
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 24 · See all- K992072Bolus Accessory SetI-Flow Corp. · 1999 · cites it directly21descendants
- K020862I-Flow Elastomeric PumpI-Flow Corp. · 2002 · 2 generations on19descendants
- K023098Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion KitMckinley Infuser · 2002 · 3 generations on17descendants
- K033039Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsMckinley, Inc. · 2003 · 4 generations on15descendants
- K032642Beeline SystemMckinley, Inc. · 2003 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K884505 | Basal/Bolus Infusors | Baxter Healthcare Corp | 1989 | 2 |
| 0 (this device) | K984638 | Paragon Bolus Accessory Set | I-Flow Corp. | 1999 | — |
| +1 | K992072 | Bolus Accessory Set | I-Flow Corp. | 1999 | — |
| +2 | K020862 | I-Flow Elastomeric Pump | I-Flow Corp. | 2002 | 1 |
| +3 | K023098 | Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion Kit | Mckinley Infuser | 2002 | — |
| +4 | K033039 | Modification to: Accufuser, Accufuser Plus, Standard Procedure Kits | Mckinley, Inc. | 2003 | — |
| +4 | K032642 | Beeline System | Mckinley, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 6 | 1 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 1 |
| 2009 | 1 | 0 |
| 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.
2 devices in this family have 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? (2)
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 |
|---|---|---|---|
| * | K884505 | Basal/Bolus InfusorsSummary page 2…lassification Panel: General Hospital and Personal Use Device Statement of Equivalence 1.2.1 The Bolus Accessory is substantially equivalent to Patient Control Module (K884505) marketed by Baxter Healthcare Corporation and the I-Flow Bolus Dispenser (K935811). 2.0 PHYSICAL SPECIFICATIONS AND DESCRIPTION… | 1989 |
| * | K935811 | Bolus DispenserSummary page 2…nce 1.2.1 The Bolus Accessory is substantially equivalent to Patient Control Module (K884505) marketed by Baxter Healthcare Corporation and the I-Flow Bolus Dispenser (K935811). 2.0 PHYSICAL SPECIFICATIONS AND DESCRIPTIONS 2.1 2.2 2.3 2.4 Description of the Bolus Accessory Wherever the Paragon pum… | 1995 |
What descends from it? (24)
See all 242 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 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.
What does this lineage say?
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 Bolus Accessory Set is intended to deliver fixed boluses of medication upon demand by the patient or heaithcare provider. The routes of administration are 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/K984638 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984638: Paragon Bolus Accessory Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984638
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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