510(k) · Cleared
ClearedPainbuster Infusion System
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 May 28, 1998 as substantially equivalent to K896422 (Burron Medical, Inc., 1990) and 2 other predicates after a 104-day review. Its family tree reaches back 1 generation to 1990. 2 of the 51 devices in its family, counting itself, have a Class I recall. 47 later devices descend from it.
- Decided
- May 28, 1998
- Review
- 104 days
- Class
- Class II
- Product code
- MEB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K896422 (1990). 3 ancestors in all. 47 later devices descend from it, 7 citing it directly. 2 of the 51 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- This deviceK980558 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
- Descendant · 4 generations on · 15 of its ownK033039 Modification to: Accufuser, Accufuser Plus, Standard Procedure KitsMckinley, Inc. · 2003
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 47 · See all- 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
- 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 |
|---|---|---|---|---|---|
| −1 | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| 0 (this device) | 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 | — |
| +4 | K033039 | Modification to: Accufuser, Accufuser Plus, Standard Procedure Kits | Mckinley, Inc. | 2003 | — |
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 |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 5 | 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), 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 |
|---|---|---|---|
| * | K896422 | Burron Ambulatory Drug Delivery SystemSummary page 2…rket via premarket notification regulation). 1.2.2 The PainBuster Infusion System is substantially equivalent in intended use to the Pain Control Infusion Pump (PCIP) (K896422) distributed by Sgarlato Laboratories, Inc. 1.2.2.1 The Sgarlato PCIP kit contains an infusion pump produced by Burron/B. Braun,… | 1990 |
| * | K944692 | C-Series HomepumpSummary page 2…e of the needle included in the PainBuster kit is the Jelco™ Catheter Introducer Needle. 12223 The PainBuster pump is substantially equivalent to the Homepump C-Series (K944692) and Homepump Eclipse (K932740) marketed by |-Flow Corporation. 1223 The PainBuster pump’s design is nearly identical to the ori… | 1995 |
| * | K932740 | Homepump NSFSummary page 2…PainBuster kit is the Jelco™ Catheter Introducer Needle. 12223 The PainBuster pump is substantially equivalent to the Homepump C-Series (K944692) and Homepump Eclipse (K932740) marketed by |-Flow Corporation. 1223 The PainBuster pump’s design is nearly identical to the original Homepump C-Series, see se… | 1993 |
| † | K813186 | Perfix Set for Epidural Anesthesia W/Tuo | 1981 |
What descends from it? (47)
See all 477 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 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 the intraoperative (soft tissue / body cavity) site for postoperative pain management. The PainBuster is intended to deliver pain medication percutaneously via an administration set attached to a catheter. The PainBuster is single use only. The PainBuster is suitable for use as an ambulatory device and is intended for use in the home environment but not limited…
Read the full statement (132 words)
The PainBuster is intended to provide continuous infusion of a local anesthetic directly into the intraoperative (soft tissue / body cavity) site for postoperative pain management.
The PainBuster is intended to deliver pain medication percutaneously via an administration set attached to a catheter.
The PainBuster is single use only.
The PainBuster is suitable for use as an ambulatory device and is intended for use in the home environment but not limited to use in the home environment.
The PainBuster is not intended for epidural, subcutaneous or vascular drug delivery.
The PainBuster is not intended for chemotherapy drugs.
No testing has been conducted to determine the efficacy of the PainBuster for the delivery of blood, blood products or TPN. The PainBuster is not intended for the delivery of blood, blood products or TPN.
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/K980558 · printed Nov 4, 2026
Cite this page
510(k) Report. “K980558: Painbuster Infusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K980558
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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