510(k) · Cleared
ClearedModification to Soaker Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I-Flow Corp. · BSO Catheter, Conduction, Anesthetic
Cleared on Jan 11, 2005 as substantially equivalent to K991543 (I-Flow Corp., 1999) and 2 other predicates after a 27-day review. Its family tree reaches back 4 generations to 1981. 11 later devices descend from it.
- Decided
- Jan 11, 2005
- Review
- 27 days
- Class
- Class II
- Product code
- BSO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K813186 (1981). 6 ancestors in all. 11 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK813186 Perfix Set for Epidural Anesthesia W/TuoBurron Medical Products, Inc. · 1981
- 3 generations backK991543 Intraop CatheterI-Flow Corp. · 1999
- 2 generations backK994374 Soaker CatheterI-Flow Corp. · 2000
- 1 generation backK022869 Soaker CatheterI-Flow Corp. · 2002
- This deviceK043456 Modification to Soaker CatheterI-Flow Corp. · 2005
- Descendant · cites it directly · 4 of its ownK143164 ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter SetKimberly-Clark Corporation · 2014
- Descendant · cites it directly · 4 of its ownK051401 ON-Q Catheter, on-Antimicrobial Catheter, Soaker Catheter, I-Flow…I-Flow Corp. · 2005
- Descendant · 2 generations on · 2 of its ownK080675 Pajunk Infiltralong Wound Infiltration Catheter KitPAJUNK GmbH Medizintechnologie · 2008
- Descendant · 2 generations on · 1 of its ownK152952 E-CathPAJUNK GmbH Medizintechnologie · 2016
- Descendant · 2 generations on · 1 of its ownK111031 Painfusor CatheterPlan 1 Health, S.R.L. · 2011
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K143164ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter SetKimberly-Clark Corporation · 2014 · cites it directly4descendants
- K051401ON-Q Catheter, on-Antimicrobial Catheter, Soaker Catheter, I-Flow CatheterI-Flow Corp. · 2005 · cites it directly4descendants
- K080675Pajunk Infiltralong Wound Infiltration Catheter KitPAJUNK GmbH Medizintechnologie · 2008 · 2 generations on2descendants
- K152952E-CathPAJUNK GmbH Medizintechnologie · 2016 · 2 generations on1descendant
- K111031Painfusor CatheterPlan 1 Health, S.R.L. · 2011 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K813186 | Perfix Set for Epidural Anesthesia W/Tuo | Burron Medical Products, Inc. | 1981 | — |
| −3 | K991543 | Intraop Catheter | I-Flow Corp. | 1999 | — |
| −2 | K994374 | Soaker Catheter | I-Flow Corp. | 2000 | — |
| −1 | K022869 | Soaker Catheter | I-Flow Corp. | 2002 | — |
| 0 (this device) | K043456 | Modification to Soaker Catheter | I-Flow Corp. | 2005 | — |
| +1 | K143164 | ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set | Kimberly-Clark Corporation | 2014 | — |
| +1 | K051401 | ON-Q Catheter, on-Antimicrobial Catheter, Soaker Catheter, I-Flow Catheter | I-Flow Corp. | 2005 | — |
| +2 | K080675 | Pajunk Infiltralong Wound Infiltration Catheter Kit | PAJUNK GmbH Medizintechnologie | 2008 | — |
| +2 | K152952 | E-Cath | PAJUNK GmbH Medizintechnologie | 2016 | — |
| +2 | K111031 | Painfusor Catheter | Plan 1 Health, S.R.L. | 2011 | — |
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 |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2020 | 2 | 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? (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 |
|---|---|---|---|
| * | K991543 | Intraop CatheterSummary page 1…Epidural Catheter Common Name: Catheter Classification Name: Catheter, Conduction, Anesthetic Existing Device: I-Flow Catheter(K991543, K994374 and K022869) Device Description: The I-Flow Catheter consists of three design options which c… | 1999 |
| * | K994374 | Soaker CatheterSummary page 1…Epidural Catheter Common Name: Catheter Classification Name: Catheter, Conduction, Anesthetic Existing Device: I-Flow Catheter(K991543, K994374 and K022869) Device Description: The I-Flow Catheter consists of three design options which can utiliz… | 2000 |
| * | K022869 | Soaker CatheterSummary page 1…Epidural Catheter Common Name: Catheter Classification Name: Catheter, Conduction, Anesthetic Existing Device: I-Flow Catheter(K991543, K994374 and K022869) Device Description: The I-Flow Catheter consists of three design options which can utilize infusion s… | 2002 |
What descends from it? (11)
See all 113 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 24 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K143164 (Kimberly-Clark Corporation, 2014) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K991543.
How does its category compare?
All BSO devicesBSO Catheter, Conduction, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
1. With I-Flow Corporation's ON-Q, PainBuster and C-bloc pain management kits; and
2. As a stand alone device to provide continuous or intermittent delivery of medication (such as local anesthetics or narcotics) to surgical wound sites and/or close proximity to nerves. Routes of administration may be intraoperative, percutaneous, epidural or perineural. The Soaker version of the I-Flow Catheter is contraindicated for the epidural space.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043456 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043456: Modification to Soaker Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043456
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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