510(k) · Cleared
ClearedEpidural Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aries Medical, Inc. · BSO Catheter, Conduction, Anesthetic
Cleared on Feb 27, 1984 after a 39-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 32 later devices descend from it.
- Decided
- Feb 27, 1984
- Review
- 39 days
- Class
- Class II
- Product code
- BSO
- Recalls
- None
- Predicates
- 0
32 later devices descend from it, 3 citing it directly.
- This deviceK840202 Epidural CatheterAries Medical, Inc. · 1984
- Descendant · cites it directly · 31 of its ownK991543 Intraop CatheterI-Flow Corp. · 1999
- 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 · 2 generations on · 10 of its ownK030830 B. Braun Nerve Block CatheterB.Braun Medical, Inc. · 2003
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K991543Intraop CatheterI-Flow Corp. · 1999 · cites it directly31descendants
- 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
- K030830B. Braun Nerve Block CatheterB.Braun Medical, Inc. · 2003 · 2 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K840202 | Epidural Catheter | Aries Medical, Inc. | 1984 | — |
| +1 | K991543 | Intraop Catheter | I-Flow Corp. | 1999 | — |
| +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 | — |
| +2 | K030830 | B. Braun Nerve Block Catheter | B.Braun Medical, Inc. | 2003 | — |
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 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (32)
See all 323 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?
- Of its descendants, K991543 (I-Flow Corp., 1999) has gone furthest, with 31 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) | — |
https://510kreport.com/device/K840202 · printed Nov 5, 2026
Cite this page
510(k) Report. “K840202: Epidural Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K840202
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026