510(k) · Cleared
ClearedMedline Reinforced Epidural Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · BSO Catheter, Conduction, Anesthetic
Cleared on Mar 4, 2019 as substantially equivalent to K140110 (Teleflex, Inc., 2015) after a 244-day review. Its family tree reaches back 3 generations to 1989. 3 of the 4 devices in its family, counting itself, have a Class I recall.
- Decided
- Mar 4, 2019
- Review
- 244 days
- Class
- Class II
- Product code
- BSO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K884552 (1989). No later device cites it as a predicate yet. 3 of the 4 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK884552 Continuous Epidural Anesthesia Kit W/Poly CatheterArrow Intl., Inc. · 1989 · Recalled (Class I)
- 2 generations backK103658 Flextip Plus Closed Tip Epidural CatherterTeleflex, Inc. · 2012 · Recalled (Class I)
- 1 generation backK140110 Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve…Teleflex, Inc. · 2015 · Recalled (Class I)
- This deviceK181782 Medline Reinforced Epidural CatheterMedline Industries, Inc. · 2019
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K884552 | Continuous Epidural Anesthesia Kit W/Poly Catheter | Arrow Intl., Inc. | 1989 | Class I |
| −2 | K103658 | Flextip Plus Closed Tip Epidural Catherter | Teleflex, Inc. | 2012 | Class I |
| −1 | K140110 | Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve Block… | Teleflex, Inc. | 2015 | Class I |
| 0 (this device) | K181782 | Medline Reinforced Epidural Catheter | Medline Industries, Inc. | 2019 | — |
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.
3 devices in this family have a Class I recall. 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 |
|---|---|---|---|
| * | K140110 | Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve Block Catheter Kit/SetSummary page 5…atory Class: Class II Regulation Number: 21 CFR 868.5120 Predicate Device Predicate Device Name: ARROW® FlexTip Plus® Epidural Catheter Predicate Device 510(k) Number: K140110 Predicate Device Indications for Use: The Arrow Epidural Catheter permits access to the epidural space for the administration of… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K140110Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve Block Catheter Kit/SetTeleflex, Inc. · 2015 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
- K103658Flextip Plus Closed Tip Epidural CatherterTeleflex, Inc. · 2012 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K884552Continuous Epidural Anesthesia Kit W/Poly CatheterArrow Intl., Inc. · 1989 · 3 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 30 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 3 of the 3 ancestors have a recall of any class; 3 have a Class I recall.
How does its category compare?
All BSO devicesBSO Catheter, Conduction, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
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 Medline Reinforced Epidural Catheter is indicated for the injection of local anesthetics into the epidural space for
patients over 22lbs. (10kg), for a duration of use up to 72 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181782 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181782: Medline Reinforced 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/K181782
Report an extraction error
Are you the manufacturer?
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