510(k) · Cleared
ClearedSubQKath Catheter and Needle Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hk Surgical · BSO Catheter, Conduction, Anesthetic
Cleared on Sep 9, 2020 as substantially equivalent to K111031 (Plan 1 Health, S.R.L., 2011) after a 253-day review. Its family tree reaches back 8 generations to 1981.
- Decided
- Sep 9, 2020
- Review
- 253 days
- Class
- Class II
- Product code
- BSO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K813186 (1981). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK813186 Perfix Set for Epidural Anesthesia W/TuoBurron Medical Products, Inc. · 1981
- 7 generations backK991543 Intraop CatheterI-Flow Corp. · 1999
- 6 generations backK994374 Soaker CatheterI-Flow Corp. · 2000
- 5 generations backK022869 Soaker CatheterI-Flow Corp. · 2002
- 4 generations backK043456 Modification to Soaker CatheterI-Flow Corp. · 2005
- 3 generations backK051401 ON-Q Catheter, on-Antimicrobial Catheter, Soaker Catheter, I-Flow…I-Flow Corp. · 2005
- 2 generations backK080675 Pajunk Infiltralong Wound Infiltration Catheter KitPAJUNK GmbH Medizintechnologie · 2008
- 1 generation backK111031 Painfusor CatheterPlan 1 Health, S.R.L. · 2011
- This deviceK193664 SubQKath Catheter and Needle SetHk Surgical · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K813186 | Perfix Set for Epidural Anesthesia W/Tuo | Burron Medical Products, Inc. | 1981 | — |
| −7 | K991543 | Intraop Catheter | I-Flow Corp. | 1999 | — |
| −6 | K994374 | Soaker Catheter | I-Flow Corp. | 2000 | — |
| −5 | K022869 | Soaker Catheter | I-Flow Corp. | 2002 | — |
| −4 | K043456 | Modification to Soaker Catheter | I-Flow Corp. | 2005 | — |
| −3 | 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 | — |
| −1 | K111031 | Painfusor Catheter | Plan 1 Health, S.R.L. | 2011 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K111031 | Painfusor CatheterSummary page 4…Classification Regulation : 868.5120 Class: II Product Code: BSO III. PREDICATE DEVICE PAINfusor Catheter (K111031)- primary predicate This predicate has not been subject to a design-related recall PAJUNK Wound Infil… | 2011 |
| † | K080675 | Pajunk Infiltralong Wound Infiltration Catheter Kit | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
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 39 years and passes through 5 companies; a new generation was cleared every 2.6 years on median.
- 1 of the 10 ancestors has a recall of any class.
How does its category compare?
All BSO devicesBSO Catheter, Conduction, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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 SubQKath Catheter and Needle Kit is intended to provide continuous and/or intermittent infusion of local anesthetics and analgesics for subcutaneous infiltration local anesthesia, peripheral plexus anesthesia and pain management during pre-operative, perioperative and post-operative periods associated with surgical procedures.
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/K193664 · printed Nov 6, 2026
Cite this page
510(k) Report. “K193664: SubQKath Catheter and Needle Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K193664
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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