510(k) · Cleared
ClearedSims Portex Epidural Catheter, 20G Model# 4910-16/17; 21G Model# 4910-18
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sims Portex, Inc. · BSO Catheter, Conduction, Anesthetic
Cleared on Oct 22, 1999 after an 88-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.
- Decided
- Oct 22, 1999
- Review
- 88 days
- Class
- Class II
- Product code
- BSO
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK992471 Sims Portex Epidural Catheter, 20G Model# 4910-16/17; 21G Model#…Sims Portex, Inc. · 1999
- Descendant · cites it directly · 3 of its ownK062005 Portex Epidural CatheterSmiths Medical Asd, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 2 of its ownK080140 Laurimed Spinal Injection SystemLaurimed, LLC · 2008
- Descendant · cites it directly · 2 of its ownK033080 Portex 24G Pediatric Epidural and Peripheral Block Anesthesia CatheterPortex, Inc. · 2004
- Descendant · 3 generations on · 1 of its ownK083909 Spinal Injection SystemLaurimed, LLC · 2009
- Descendant · 2 generations on · 1 of its ownK062902 Pajunks Epilong Set PediatricPAJUNK GmbH Medizintechnologie · 2007
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K062005Portex Epidural CatheterSmiths Medical Asd, Inc. · 2006 · cites it directly3descendants
- K080140Laurimed Spinal Injection SystemLaurimed, LLC · 2008 · 2 generations on2descendants
- K033080Portex 24G Pediatric Epidural and Peripheral Block Anesthesia CatheterPortex, Inc. · 2004 · cites it directly2descendants
- K083909Spinal Injection SystemLaurimed, LLC · 2009 · 3 generations on1descendant
- K062902Pajunks Epilong Set PediatricPAJUNK GmbH Medizintechnologie · 2007 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K992471 | Sims Portex Epidural Catheter, 20G Model# 4910-16/17; 21G Model# 4910-18 | Sims Portex, Inc. | 1999 | — |
| +1 | K062005 | Portex Epidural Catheter | Smiths Medical Asd, Inc. | 2006 | 1 |
| +2 | K080140 | Laurimed Spinal Injection System | Laurimed, LLC | 2008 | — |
| +1 | K033080 | Portex 24G Pediatric Epidural and Peripheral Block Anesthesia Catheter | Portex, Inc. | 2004 | — |
| +3 | K083909 | Spinal Injection System | Laurimed, LLC | 2009 | — |
| +2 | K062902 | Pajunks Epilong Set Pediatric | PAJUNK GmbH Medizintechnologie | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2012 | 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? (2)
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 |
|---|---|---|---|
| * | — | SIMS Portex epidural catheter, 4910-16/17, 20g nylon, closed-end, three-eyed Named without a submission number | |
| * | — | SIMS Portex epidural catheter, 4910-18, 21g nylon, closed-end, three-eyed Named without a submission number |
What descends from it? (9)
3 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, K062005 (Smiths Medical Asd, Inc., 2006) has gone furthest, with 3 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 SIMS Portex Epidural Catheter is indicated for the injection of local anesthetics into the epidural space.
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/K992471 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992471: Sims Portex Epidural Catheter, 20G Model# 4910-16/17; 21G Model# 4910-18.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992471
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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