510(k) · Cleared
ClearedPainbuster Infusion Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I-Flow Corp. · MEB Pump, Infusion, Elastomeric
Cleared on Nov 18, 1998 as substantially equivalent to K980558 (I-Flow Corp., 1998) and 2 other predicates after an 89-day review. Its family tree reaches back 2 generations to 1990. 2 of the 47 devices in its family, counting itself, have a Class I recall. 42 later devices descend from it.
- Decided
- Nov 18, 1998
- Review
- 89 days
- Class
- Class II
- Product code
- MEB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K896422 (1990). 4 ancestors in all. 42 later devices descend from it, 7 citing it directly. 2 of the 47 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 1 generation backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
- This deviceK982946 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
- Descendant · 4 generations on · 15 of its ownK033039 Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsMckinley, Inc. · 2003
- Descendant · cites it directly · 11 of its ownK984146 Paragon InfusionI-Flow Corp. · 1999
Showing 5 of 42 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 42 · See all- 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
- K033039Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsMckinley, Inc. · 2003 · 4 generations on15descendants
- K984146Paragon InfusionI-Flow Corp. · 1999 · cites it directly11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| −1 | K980558 | Painbuster Infusion System | I-Flow Corp. | 1998 | — |
| 0 (this device) | 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 | — |
| +4 | K033039 | Modification to: Accufuser, Accufuser Plus, Standard Procedure Kits | Mckinley, Inc. | 2003 | — |
| +1 | K984146 | Paragon Infusion | I-Flow Corp. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 4 | 0 |
| 2002 | 6 | 1 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 7 | 0 |
| 2006 | 6 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 1 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2016 | 3 | 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 MEB device
- #1 K250234 SMARTeZ™ Elastomeric Infusion Pump (RS series)score 14.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K980558 | Painbuster Infusion SystemSummary page 2…rket an extension to the current PainBuster product line, including labeling changes and additional models and components. 1.1.1.1 All models previously submitted under K980558 are included under this premarket notification. Trade Name: PainBuster™ Infusion Kit Common Name: Elastomeric Infusion Pump Kit… | 1998 |
| * | K896422 | Burron Ambulatory Drug Delivery SystemSummary page 2…0). The PainBuster Kit is substantially equivalent to the PainBuster Infusion System (K980558) marketed by I-Flow Corporation and the Pain Control Infusion Pump (PCIP) (K896422) marketed by Sgarlato Laboratories, Inc. 2.0 PHYSICAL SPECIFICATIONS AND DESCRIPTIONS 2.1 Description of Device 211 2.1.2 Th… | 1990 |
| * | K944692 | C-Series HomepumpSummary page 2…via premarket notification regulation). The PainBuster pump is an additional model to the Homepump elastomeric infusion pumps marketed by I-Flow Corporation (C-Series - K944692 and Eclipse - K932740). The PainBuster Kit is substantially equivalent to the PainBuster Infusion System (K980558) marketed by I… | 1995 |
What descends from it? (42)
See all 427 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?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 8.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K984502 (I-Flow Corp., 1999) has gone furthest, with 33 descendants of its own.
- 6 other devices also cite its predicate K980558.
How does its category compare?
All MEB devicesMEB Pump, Infusion, Elastomeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEB
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MEB
42in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEB
17in 2018
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · MEB
1,408in 2025
MAUDE reports naming product code MEB, 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 | 5 | 42 | 1 | 110 |
| 2008 | 2 | — | 3 | 444 |
| 2009 | 1 | — | 48 | 798 |
| 2010 | 0 | — | 2 | 1,827 |
| 2011 | 0 | — | 8 (1) | 2,265 |
| 2012 | 0 | — | 0 | 1,976 |
| 2013 | 1 | — | 2 (1) | 1,956 |
| 2014 | 1 | — | 0 | 2,695 |
| 2015 | 0 | — | 0 | 2,980 |
| 2016 | 1 | — | 0 | 2,147 |
| 2017 | 0 | — | 0 | 1,653 |
| 2018 | 0 | — | 17 | 1,473 |
| 2019 | 1 | — | 0 | 974 |
| 2020 | 0 | — | 0 | 2,732 |
| 2021 | 0 | — | 0 | 1,802 |
| 2022 | 0 | — | 0 | 1,288 |
| 2023 | 0 | — | 0 | 1,248 |
| 2024 | 2 | — | 0 | 1,424 |
| 2025 | 0 | — | 0 | 1,408 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The PainBuster is intended to provide continuous infusion of a local anesthetic directly into an intraoperative (soft tissue / body cavity) site for general surgery for postoperative pain management. Additional routes of administration include percutaneous and subcutaneous infusion.
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/K982946 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982946: Painbuster Infusion Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982946
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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