510(k) · Cleared
Recalled · 2009Portex Epidural Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smiths Medical Asd, Inc. · BSO Catheter, Conduction, Anesthetic
Cleared on Oct 18, 2006 as substantially equivalent to K992471 (Sims Portex, Inc., 1999) after a 93-day review. Its family tree reaches back 1 generation to 1999. 3 later devices descend from it. It has been recalled once.
- Decided
- Oct 18, 2006
- Review
- 93 days
- Class
- Class II
- Product code
- BSO
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K992471 (1999). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK992471 Sims Portex Epidural Catheter, 20G Model# 4910-16/17; 21G Model#…Sims Portex, Inc. · 1999
- This deviceK062005 Portex Epidural CatheterSmiths Medical Asd, Inc. · 2006
- Descendant · cites it directly · 2 of its ownK080140 Laurimed Spinal Injection SystemLaurimed, LLC · 2008
- Descendant · 2 generations on · 1 of its ownK083909 Spinal Injection SystemLaurimed, LLC · 2009
- Descendant · 3 generations on · 0 of its ownK091818 Laurimed Spinal Injection SystemLaurimed, LLC · 2009
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K992471 | Sims Portex Epidural Catheter, 20G Model# 4910-16/17; 21G Model# 4910-18 | Sims Portex, Inc. | 1999 | — |
| 0 (this device) | K062005 | Portex Epidural Catheter | Smiths Medical Asd, Inc. | 2006 | — |
| +1 | K080140 | Laurimed Spinal Injection System | Laurimed, LLC | 2008 | — |
| +2 | K083909 | Spinal Injection System | Laurimed, LLC | 2009 | — |
| +3 | K091818 | Laurimed Spinal Injection System | Laurimed, LLC | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 2 | 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 |
|---|---|---|---|
| * | K992471 | Sims Portex Epidural Catheter, 20G Model# 4910-16/17; 21G Model# 4910-18Summary page 1…sthesia Conduction Catheter Classification Name: Anesthesia Conduction Catheter (21 CFR 868.5120, Product Code BSO) Predicate Device(s): K992471, SIMS Portex Epidural Catheter Device Description: The epidural catheter is made of flexible, nylon… | 1999 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080140 | Laurimed Spinal Injection System | 2008 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 15, 2009 | Not classified | Z-2050-2009 | Mixed-up of materials/components | Portex Continuous Epidural Tray was distributed with a 20G closed end, three eyed, nylon catheter without a stylet instead of the 20 G open end Teflon catheter with stylet specified on the label. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 Epidural Catheter is indicated for the injection of local anesthetics into the epidural space.
The duration of use should not exceed 72 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062005 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062005: Portex Epidural Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062005
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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