510(k) · Cleared
ClearedBurron Ambulatory Drug Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Burron Medical, Inc. · FRN Pump, Infusion
Cleared on May 9, 1990 after a 182-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 of the 50 devices in its family, counting itself, have a Class I recall. 49 later devices descend from it.
- Decided
- May 9, 1990
- Review
- 182 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 0
49 later devices descend from it, 8 citing it directly. 2 of the 50 devices in this family, counting this one, have a Class I recall.
- This deviceK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- Descendant · cites it directly · 47 of its ownK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
- Descendant · cites it directly · 42 of its ownK982946 Painbuster Infusion KitI-Flow Corp. · 1998
- Descendant · cites it directly · 33 of its ownK984502 Nerve Block Infusion KitI-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
Showing 5 of 49 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 49 · See all- K980558Painbuster Infusion SystemI-Flow Corp. · 1998 · cites it directly47descendants
- K982946Painbuster Infusion KitI-Flow Corp. · 1998 · cites it directly42descendants
- K984502Nerve Block Infusion KitI-Flow Corp. · 1999 · cites it directly33descendants
- K020862I-Flow Elastomeric PumpI-Flow Corp. · 2002 · 2 generations on19descendants
- K023098Accufuser, Accufuser Plus, Standard Procedure Kit, Accufuser Infusion KitMckinley Infuser · 2002 · 3 generations on17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| +1 | K980558 | Painbuster Infusion System | I-Flow Corp. | 1998 | — |
| +1 | K982946 | Painbuster Infusion Kit | I-Flow Corp. | 1998 | — |
| +1 | K984502 | Nerve Block Infusion Kit | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 6 | 0 |
| 2002 | 7 | 1 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 7 | 0 |
| 2006 | 7 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 1 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2016 | 3 | 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? (49)
See all 498 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980558 | Painbuster Infusion System | 1998 | 47 |
| K982946 | Painbuster Infusion Kit | 1998 | 42 |
| K984502 | Nerve Block Infusion Kit | 1999 | 33 |
| K984146 | Paragon Infusion | 1999 | 11 |
| K984063 | Paragon Basal/Bolus Administration Set | 1999 | 9 |
| K990101 | Pain Control Infusion Pump | 1999 | 7 |
| K992551 | Alpha Infusion Pump | 1999 | 5 |
| K990425 | Sidekick Infusion Kit | 1999 | 0 |
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, K980558 (I-Flow Corp., 1998) has gone furthest, with 47 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/K896422 · printed Nov 5, 2026
Cite this page
510(k) Report. “K896422: Burron Ambulatory Drug Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K896422
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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