510(k) · Cleared
ClearedON-Q Catheter, on-Antimicrobial Catheter, Soaker Catheter, I-Flow 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 Nov 30, 2005 as substantially equivalent to K043456 (I-Flow Corp., 2005) after a 183-day review. Its family tree reaches back 5 generations to 1981. 4 later devices descend from it.
- Decided
- Nov 30, 2005
- Review
- 183 days
- Class
- Class II
- Product code
- BSO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K813186 (1981). 7 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK813186 Perfix Set for Epidural Anesthesia W/TuoBurron Medical Products, Inc. · 1981
- 4 generations backK991543 Intraop CatheterI-Flow Corp. · 1999
- 3 generations backK994374 Soaker CatheterI-Flow Corp. · 2000
- 2 generations backK022869 Soaker CatheterI-Flow Corp. · 2002
- 1 generation backK043456 Modification to Soaker CatheterI-Flow Corp. · 2005
- This deviceK051401 ON-Q Catheter, on-Antimicrobial Catheter, Soaker Catheter, I-Flow…I-Flow Corp. · 2005
- Descendant · cites it directly · 2 of its ownK080675 Pajunk Infiltralong Wound Infiltration Catheter KitPAJUNK GmbH Medizintechnologie · 2008
- Descendant · cites it directly · 1 of its ownK111031 Painfusor CatheterPlan 1 Health, S.R.L. · 2011
- Descendant · 2 generations on · 0 of its ownK193664 SubQKath Catheter and Needle SetHk Surgical · 2020
- Descendant · cites it directly · 0 of its ownK072702 Stryker Antimic CatheterStryker Instruments, Instruments Div. · 2008
Most influential descendants
Showing 4 of 4 · See all- K080675Pajunk Infiltralong Wound Infiltration Catheter KitPAJUNK GmbH Medizintechnologie · 2008 · cites it directly2descendants
- K111031Painfusor CatheterPlan 1 Health, S.R.L. · 2011 · cites it directly1descendant
- K193664SubQKath Catheter and Needle SetHk Surgical · 2020 · 2 generations on0descendants
- K072702Stryker Antimic CatheterStryker Instruments, Instruments Div. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K813186 | Perfix Set for Epidural Anesthesia W/Tuo | Burron Medical Products, Inc. | 1981 | — |
| −4 | K991543 | Intraop Catheter | I-Flow Corp. | 1999 | — |
| −3 | K994374 | Soaker Catheter | I-Flow Corp. | 2000 | — |
| −2 | K022869 | Soaker Catheter | I-Flow Corp. | 2002 | — |
| −1 | K043456 | Modification to Soaker Catheter | I-Flow Corp. | 2005 | — |
| 0 (this device) | 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 | — |
| +1 | K111031 | Painfusor Catheter | Plan 1 Health, S.R.L. | 2011 | — |
| +2 | K193664 | SubQKath Catheter and Needle Set | Hk Surgical | 2020 | — |
| +1 | K072702 | Stryker Antimic Catheter | Stryker Instruments, Instruments Div. | 2008 | — |
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 |
|---|---|---|
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | K043456 | Modification to Soaker CatheterSummary page 1…r Names: ON-Q SilverSoaker Catheter, Common Name: Catheter Classification Name: Catheter, Conduction, Anesthetic Existing Device: ON-Q Catheter (K043456, previously identified as I-Flow Catheter) Device Description: The ON-Q SilverSoaker Catheter consists… | 2005 |
What descends from it? (4)
3 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 2.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K080675 (PAJUNK GmbH Medizintechnologie, 2008) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K043456.
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. The ON-Q SilverSoaker Catheter is intended 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. The ON-Q SilverSoaker Catheter is contraindicated for the epidural space and in neonatal populations. 2. The ON-Q SilverSoaker Catheter contains an antimicrobial agent which may destroy or inhibit the growth…
Read the full statement (107 words)
1. The ON-Q SilverSoaker Catheter is intended 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. The ON-Q SilverSoaker Catheter is contraindicated for the epidural space and in neonatal populations.
2. The ON-Q SilverSoaker Catheter contains an antimicrobial agent which may destroy or inhibit the growth of microorganisms on both the inner and outer surfaces of the catheter. The antimicrobial agent is intended to reduce the possibility that the catheter may become microbially compromised. The antimicrobial agent is not intended to be used as a treatment for existing infections.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051401 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051401: ON-Q Catheter, on-Antimicrobial Catheter, Soaker Catheter, I-Flow Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051401
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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