510(k) · Cleared
ClearedON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kimberly-Clark Corporation · BSO Catheter, Conduction, Anesthetic
Cleared on Dec 2, 2014 as substantially equivalent to K043456 (I-Flow Corp., 2005) and 1 other predicate after a 29-day review. Its family tree reaches back 5 generations to 1981. 4 later devices descend from it.
- Decided
- Dec 2, 2014
- Review
- 29 days
- Class
- Class II
- Product code
- BSO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K813186 (1981). 8 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 deviceK143164 ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter SetKimberly-Clark Corporation · 2014
- Descendant · cites it directly · 1 of its ownK152952 E-CathPAJUNK GmbH Medizintechnologie · 2016
- Descendant · 2 generations on · 0 of its ownK202699 E-Cath STIM acc. TsuiPAJUNK GmbH Medizintechnologie · 2020
- Descendant · cites it directly · 0 of its ownK171193 Certa CatheterFerrosan Medical Devices Sp. Z.O.O. · 2017
- Descendant · cites it directly · 0 of its ownK161232 ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic…Halyard Health · 2016
Most influential descendants
Showing 4 of 4 · See all- K152952E-CathPAJUNK GmbH Medizintechnologie · 2016 · cites it directly1descendant
- K202699E-Cath STIM acc. TsuiPAJUNK GmbH Medizintechnologie · 2020 · 2 generations on0descendants
- K171193Certa CatheterFerrosan Medical Devices Sp. Z.O.O. · 2017 · cites it directly0descendants
- K161232ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block KitHalyard Health · 2016 · 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) | K143164 | ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set | Kimberly-Clark Corporation | 2014 | — |
| +1 | K152952 | E-Cath | PAJUNK GmbH Medizintechnologie | 2016 | — |
| +2 | K202699 | E-Cath STIM acc. Tsui | PAJUNK GmbH Medizintechnologie | 2020 | — |
| +1 | K171193 | Certa Catheter | Ferrosan Medical Devices Sp. Z.O.O. | 2017 | — |
| +1 | K161232 | ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve… | Halyard Health | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1998 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 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 9.5 · 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 |
|---|---|---|---|
| * | K043456 | Modification to Soaker CatheterSummary page 4…alth currently markets the I-Flow Catheter and consists of Devices: Device three design options which can utilize infusion segments ranging from epidural to 10 inches K043456). The EchoBright* Echogenic PNB Needle is a peripheral nerve block insulated needle with graduated centimeter markings to determ… | 2005 |
| * | K111355 | EchobrightSummary page 4…ter the deflection of ultrasound waves for the needle such that a high percentage reach the ultrasound probe for improved visualization of the needle position in tissue (K111355). The ON-Q* QuikBloc* Over-the-Needle (OTN) Catheter Set, subject Special 510(k): Device Modification ON-Q QuikBloc® Over-the-… | 2011 |
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 33 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K152952 (PAJUNK GmbH Medizintechnologie, 2016) has gone furthest, with 1 descendant 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. 2014, 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 ON-Q* QuikBloc* Over-the Needle Catheter Set is indicated for delivery of medication for regional anesthesia and pain management. Route of administration may be intraoperative, percutaneous, or perineural. The ON-Q* QuikBloc* Over-the-Needle Catheter Set is contraindicated for the epidural space.
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/K143164 · printed Nov 4, 2026
Cite this page
510(k) Report. “K143164: ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K143164
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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