510(k) · Cleared
Recalled · Class II · 2017Feth-R-Kath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epimed International, Inc. · BSO Catheter, Conduction, Anesthetic
Cleared on Aug 26, 1998 after a 135-day review. The FDA summary names its predicate without a number. 24 later devices descend from it. It has been recalled 2 times.
- Decided
- Aug 26, 1998
- Review
- 135 days
- Class
- Class II
- Product code
- BSO
- Recalls
- 2
- Predicates
- 0
24 later devices descend from it, 4 citing it directly.
- This deviceK981329 Feth-R-KathEpimed International, Inc. · 1998
- Descendant · cites it directly · 18 of its ownK994374 Soaker CatheterI-Flow Corp. · 2000
- Descendant · 2 generations on · 12 of its ownK022869 Soaker CatheterI-Flow Corp. · 2002
- Descendant · 2 generations on · 11 of its ownK043456 Modification to Soaker CatheterI-Flow Corp. · 2005
- Descendant · 3 generations on · 4 of its ownK143164 ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter SetKimberly-Clark Corporation · 2014
- Descendant · 3 generations on · 4 of its ownK051401 ON-Q Catheter, on-Antimicrobial Catheter, Soaker Catheter, I-Flow…I-Flow Corp. · 2005
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K994374Soaker CatheterI-Flow Corp. · 2000 · cites it directly18descendants
- K022869Soaker CatheterI-Flow Corp. · 2002 · 2 generations on12descendants
- K043456Modification to Soaker CatheterI-Flow Corp. · 2005 · 2 generations on11descendants
- K143164ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter SetKimberly-Clark Corporation · 2014 · 3 generations on4descendants
- K051401ON-Q Catheter, on-Antimicrobial Catheter, Soaker Catheter, I-Flow CatheterI-Flow Corp. · 2005 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981329 | Feth-R-Kath | Epimed International, Inc. | 1998 | — |
| +1 | K994374 | Soaker Catheter | I-Flow Corp. | 2000 | — |
| +2 | K022869 | Soaker Catheter | I-Flow Corp. | 2002 | — |
| +2 | K043456 | Modification to Soaker Catheter | I-Flow Corp. | 2005 | — |
| +3 | K143164 | ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set | Kimberly-Clark Corporation | 2014 | — |
| +3 | K051401 | ON-Q Catheter, on-Antimicrobial Catheter, Soaker Catheter, I-Flow Catheter | I-Flow Corp. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2008 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | — | Arrow International Flex Tip Plus® epidural catheter Named without a submission number |
What descends from it? (24)
See all 244 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 28, 2017 | Class II | Z-2313-2021 | Process control | Potential for stylet to protrude from the distal end of the catheter |
| Dec 28, 2017 | Class II | Z-2312-2021 | Process control | Potential for stylet to protrude from the distal end of the catheter |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K994374 (I-Flow Corp., 2000) has gone furthest, with 18 descendants of its own.
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?
The Epimed Feth-R-Kath epidural catheter is intended for administration of local anesthetics into the epidural space to provide continuous epidural or caudal anesthesia for up to 72 hours.
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/K981329 · printed Nov 5, 2026
Cite this page
510(k) Report. “K981329: Feth-R-Kath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K981329
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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