510(k) · Cleared
ClearedMckinley Saturation Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mckinley Medical, LLC · FRN Pump, Infusion
Cleared on Apr 12, 2006 as substantially equivalent to K031600 (Micor, Inc., 2003) and 2 other predicates after an 85-day review. Its family tree reaches back 3 generations to 1981.
- Decided
- Apr 12, 2006
- Review
- 85 days
- Class
- Class II
- Product code
- FRN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K813186 (1981). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK813186 Perfix Set for Epidural Anesthesia W/TuoBurron Medical Products, Inc. · 1981
- 2 generations backK991543 Intraop CatheterI-Flow Corp. · 1999
- 1 generation backK994374 Soaker CatheterI-Flow Corp. · 2000
- This deviceK060119 Mckinley Saturation CatheterMckinley Medical, LLC · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K813186 | Perfix Set for Epidural Anesthesia W/Tuo | Burron Medical Products, Inc. | 1981 | — |
| −2 | K991543 | Intraop Catheter | I-Flow Corp. | 1999 | — |
| −1 | K994374 | Soaker Catheter | I-Flow Corp. | 2000 | — |
| 0 (this device) | K060119 | Mckinley Saturation Catheter | Mckinley Medical, LLC | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 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 FRN? 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 FRN device
- #1 K253703 RemunityPRO+ Pump for Remodulin®…score 12.6 · 4 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 |
|---|---|---|---|
| * | K031600 | Conduction CatheterSummary page 1…Regulation Number: Panel: 73 Product Code: BSO Predicate Devices Micor Wundcath Conduction Catheter, K031600 & Demonstrating Substantial K003966 Equivalence: I-Flow Soaker Catheter, K994374 Statement of S… | 2003 |
| * | K003966 | Wundcath Conduction CatheterSummary page 1…: 73 Product Code: BSO Predicate Devices Micor Wundcath Conduction Catheter, K031600 & Demonstrating Substantial K003966 Equivalence: I-Flow Soaker Catheter, K994374 Statement of Substantial Equivalence: The McKinley Saturatio… | 2001 |
| * | K994374 | Soaker CatheterSummary page 1…ate Devices Micor Wundcath Conduction Catheter, K031600 & Demonstrating Substantial K003966 Equivalence: I-Flow Soaker Catheter, K994374 Statement of Substantial Equivalence: The McKinley Saturation Catheter Tm is substantially equivalent to the Micor Wundcath Cond… | 2000 |
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 25 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- 1 of the 11 ancestors has a recall of any class.
How does its category compare?
All FRN devicesFRN Pump, Infusion: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FRN
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRN
172in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRN
7in 2025
Class I (37 since 2007) Class II/III not classified
Adverse event reports per year · FRN
52,792in 2025
MAUDE reports naming product code FRN, 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 | 12 | 102 | 15 | 1,086 |
| 2008 | 8 | 89 | 24 | 8,261 |
| 2009 | 9 | 66 | 102 | 1,952 |
| 2010 | 3 | 93 | 37 | 6,133 |
| 2011 | 3 | 103 | 69 | 41,367 |
| 2012 | 4 | 217 | 42 (2) | 15,482 |
| 2013 | 6 | 312 | 22 (3) | 40,082 |
| 2014 | 6 | 172 | 4 (3) | 94,180 |
| 2015 | 3 | 232 | 5 | 26,742 |
| 2016 | 3 | 301 | 7 (1) | 16,560 |
| 2017 | 3 | 305 | 13 | 12,060 |
| 2018 | 3 | 267 | 1 | 16,591 |
| 2019 | 2 | — | 18 (1) | 15,850 |
| 2020 | 1 | — | 16 (5) | 94,186 |
| 2021 | 2 | — | 3 (2) | 199,342 |
| 2022 | 6 | 268 | 2 | 888,020 |
| 2023 | 7 | 265 | 16 (10) | 165,838 |
| 2024 | 5 | 103 | 9 (4) | 57,730 |
| 2025 | 8 | 172 | 7 (4) | 52,792 |
| 2026 | 2 | — | 11 (2) | — |
What is it indicated for?
The McKinley Saturation Catheter is intended for continuous and/or intermittent infusion of pain medication to surgical wound sites and/or close proximity to nerves outside of the epidural space. Routes of administration may be intraoperative, subcutaneous or percutaneous.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060119 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060119: Mckinley Saturation Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060119
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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