510(k) · Cleared
Cleared3M IV Flow Regulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · LDR Controller, Infusion, Intravascular, Electronic
Cleared on Feb 26, 1990 after an 80-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 23 devices in its family, counting itself, have a Class I recall. 22 later devices descend from it.
- Decided
- Feb 26, 1990
- Review
- 80 days
- Class
- Class II
- Product code
- LDR
- Recalls
- None
- Predicates
- 0
22 later devices descend from it, 1 citing it directly. 2 of the 23 devices in this family, counting this one, have a Class I recall.
- This deviceK896907 3M IV Flow Regulator3M Company · 1990
- Descendant · cites it directly · 21 of its ownK991513 Homepump C-Series and Homepump C-Series One-Step KvoI-Flow Corp. · 1999 · Recalled
- 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 22 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 22 · See all- K991513Homepump C-Series and Homepump C-Series One-Step KvoI-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 |
|---|---|---|---|---|---|
| 0 (this device) | K896907 | 3M IV Flow Regulator | 3M Company | 1990 | — |
| +1 | K991513 | Homepump C-Series and Homepump C-Series One-Step Kvo | I-Flow Corp. | 1999 | 1 |
| +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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2002 | 4 | 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 LDR device
- #1 K232316 DEKA Infusion System, DEKA Administration Setscore 10.5 · 3 generations · no Class I recall
- #2 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? (22)
See all 221 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991513 | Homepump C-Series and Homepump C-Series One-Step Kvo | 1999 | 21 |
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?
- Of its descendants, K991513 (I-Flow Corp., 1999) has gone furthest, with 21 descendants of its own.
How does its category compare?
All LDR devicesLDR Controller, Infusion, Intravascular, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LDR
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LDR
Too few LDR 510(k)s in any year since 2007 to give a median.
Recalls per year · LDR
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LDR
3in 2023
MAUDE reports naming product code LDR, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 4 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 1 | 2 |
| 2018 | 0 | — | 0 | 22 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 3 |
| 2024 | 2 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K896907 · printed Nov 6, 2026
Cite this page
510(k) Report. “K896907: 3M IV Flow Regulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K896907
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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