510(k) · Cleared
Recalled · Class II · 2013Basal/Bolus Infusors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · FRN Pump, Infusion
Cleared on Jul 14, 1989 after a 262-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 26 devices in its family, counting itself, have a Class I recall. 25 later devices descend from it. It has been recalled 2 times.
- Decided
- Jul 14, 1989
- Review
- 262 days
- Class
- Class II
- Product code
- FRN
- Recalls
- 2
- Predicates
- 0
25 later devices descend from it, 2 citing it directly. 2 of the 26 devices in this family, counting this one, have a Class I recall.
- This deviceK884505 Basal/Bolus InfusorsBaxter Healthcare Corp · 1989
- Descendant · cites it directly · 24 of its ownK984638 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
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 25 · See all- K984638Paragon Bolus Accessory SetI-Flow Corp. · 1999 · cites it directly24descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K884505 | Basal/Bolus Infusors | Baxter Healthcare Corp | 1989 | — |
| +1 | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 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), 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 FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (25)
See all 252 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 7, 2013 | Class II | Z-1606-2013 | Nonconforming Material/Component | Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved… |
| Jun 7, 2013 | Class II | Z-1610-2013 | Device Design | Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer. |
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?
- Of its descendants, K984638 (I-Flow Corp., 1999) has gone furthest, with 24 descendants of its own.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, 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 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
https://510kreport.com/device/K884505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K884505: Basal/Bolus Infusors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K884505
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026