510(k) · Cleared
ClearedPainfusor Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Plan 1 Health, S.R.L. · BSO Catheter, Conduction, Anesthetic
Cleared on Jul 8, 2011 as substantially equivalent to K051401 (I-Flow Corp., 2005) and 1 other predicate after an 85-day review. Its family tree reaches back 7 generations to 1981. 1 later device descends from it.
- Decided
- Jul 8, 2011
- Review
- 85 days
- Class
- Class II
- Product code
- BSO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K813186 (1981). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backK813186 Perfix Set for Epidural Anesthesia W/TuoBurron Medical Products, Inc. · 1981
- 6 generations backK991543 Intraop CatheterI-Flow Corp. · 1999
- 5 generations backK994374 Soaker CatheterI-Flow Corp. · 2000
- 4 generations backK022869 Soaker CatheterI-Flow Corp. · 2002
- 3 generations backK043456 Modification to Soaker CatheterI-Flow Corp. · 2005
- 2 generations backK051401 ON-Q Catheter, on-Antimicrobial Catheter, Soaker Catheter, I-Flow…I-Flow Corp. · 2005
- 1 generation backK080675 Pajunk Infiltralong Wound Infiltration Catheter KitPAJUNK GmbH Medizintechnologie · 2008
- This deviceK111031 Painfusor CatheterPlan 1 Health, S.R.L. · 2011
- Descendant · cites it directly · 0 of its ownK193664 SubQKath Catheter and Needle SetHk Surgical · 2020
Most influential descendants
Showing 1 of 1 · See all- K193664SubQKath Catheter and Needle SetHk Surgical · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K813186 | Perfix Set for Epidural Anesthesia W/Tuo | Burron Medical Products, Inc. | 1981 | — |
| −6 | K991543 | Intraop Catheter | I-Flow Corp. | 1999 | — |
| −5 | K994374 | Soaker Catheter | I-Flow Corp. | 2000 | — |
| −4 | K022869 | Soaker Catheter | I-Flow Corp. | 2002 | — |
| −3 | K043456 | Modification to Soaker Catheter | I-Flow Corp. | 2005 | — |
| −2 | K051401 | ON-Q Catheter, on-Antimicrobial Catheter, Soaker Catheter, I-Flow Catheter | I-Flow Corp. | 2005 | — |
| −1 | K080675 | Pajunk Infiltralong Wound Infiltration Catheter Kit | PAJUNK GmbH Medizintechnologie | 2008 | — |
| 0 (this device) | K111031 | Painfusor Catheter | Plan 1 Health, S.R.L. | 2011 | — |
| +1 | K193664 | SubQKath Catheter and Needle Set | Hk Surgical | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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.
Planning a device in BSO? 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 BSO device
- #1 K241410 EDEN ControlCathscore 9.4 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K051401 | ON-Q Catheter, on-Antimicrobial Catheter, Soaker Catheter, I-Flow CatheterSummary page 1…Kit (1(080675). SUBSTANTIALLY EQUIVALENT To: The PAlNfusor Catheter is substantially equivalent to the I-Flow Corporation's On-Q SliverSoaker Catheter, (K051401I), and Pajunk's Wound Infiltration Catheter Kit (K(080675). Both predicate devices are Class II devices, and are substantially eq… | 2005 |
| * | K080675 | Pajunk Infiltralong Wound Infiltration Catheter KitSummary page 1…low Corporation's On-Q SliverSoaker Catheter, (K(051401), and Pajunk's Wound Infiltration Catheter Kit (1(080675). SUBSTANTIALLY EQUIVALENT To: The PAlNfusor Catheter is substantially equivalent to the I-Flow Corporation's On-Q Sliver… | 2008 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193664 | SubQKath Catheter and Needle Set | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 30 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K193664 (Hk Surgical, 2020) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K051401.
How does its category compare?
All BSO devicesBSO Catheter, Conduction, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · BSO
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSO
205in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSO
2so far in 2026, the most since 2007
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BSO
139in 2025
MAUDE reports naming product code BSO, 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 | 2 | — | 0 | 18 |
| 2008 | 3 | 155 | 0 | 14 |
| 2009 | 1 | — | 1 | 71 |
| 2010 | 1 | — | 0 | 57 |
| 2011 | 4 | 109 | 0 | 31 |
| 2012 | 0 | — | 0 | 52 |
| 2013 | 1 | — | 0 | 73 |
| 2014 | 2 | — | 0 | 45 |
| 2015 | 1 | — | 0 | 43 |
| 2016 | 5 | 281 | 0 | 71 |
| 2017 | 3 | 205 | 0 | 38 |
| 2018 | 2 | — | 0 | 80 |
| 2019 | 2 | — | 0 | 779 |
| 2020 | 2 | — | 0 | 159 |
| 2021 | 0 | — | 0 | 146 |
| 2022 | 0 | — | 0 | 135 |
| 2023 | 2 | — | 0 | 79 |
| 2024 | 0 | — | 0 | 98 |
| 2025 | 1 | — | 0 | 139 |
| 2026 | 0 | — | 2 (1) | — |
What is it indicated for?
The PAINfusor Catheter, along with related accessory devices, is intended for use to provide
continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to or
around surgical wound sites for preoperative, perioperative and postoperative pain management.
Routes of administration may be intraoperative or percutaneous.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111031: Painfusor Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111031
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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