510(k) · Cleared
ClearedMedline 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 7, 2016 as substantially equivalent to K042488 (B.Braun Medical, Inc., 2004) after a 353-day review. Its family tree reaches back 6 generations to 1990. 1 of the 16 devices in its family, counting itself, has a Class I recall.
- Decided
- Mar 7, 2016
- Review
- 353 days
- Class
- Class II
- Product code
- BSO
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K896422 (1990). 15 ancestors in all, the oldest K801912 (1980). No later device cites it as a predicate yet. 1 of the 16 devices in this family, counting this one, has a Class I recall.
- Root · 6 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 5 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
- 4 generations backK982946 Painbuster Infusion KitI-Flow Corp. · 1998
- 3 generations backK984502 Nerve Block Infusion KitI-Flow Corp. · 1999
- 2 generations backK030830 B. Braun Nerve Block CatheterB.Braun Medical, Inc. · 2003
- 1 generation backK042488 Perifix Catheter and Contiplex CatheterB.Braun Medical, Inc. · 2004
- This deviceK150731 Medline Epidural CatheterMedline Industries, Inc. · 2016
Class I recalls in this family
- K801912 Arrow Positive Placement Con/Epidural an4 generations back · 1980
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| −5 | K980558 | Painbuster Infusion System | I-Flow Corp. | 1998 | — |
| −4 | K982946 | Painbuster Infusion Kit | I-Flow Corp. | 1998 | — |
| −3 | K984502 | Nerve Block Infusion Kit | I-Flow Corp. | 1999 | — |
| −2 | K030830 | B. Braun Nerve Block Catheter | B.Braun Medical, Inc. | 2003 | — |
| −1 | K042488 | Perifix Catheter and Contiplex Catheter | B.Braun Medical, Inc. | 2004 | — |
| 0 (this device) | K150731 | Medline Epidural Catheter | Medline Industries, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 1 |
| 1981 | 1 | 0 |
| 1984 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 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.
1 device in this family has 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 |
|---|---|---|---|
| * | K042488 | Perifix Catheter and Contiplex CatheterSummary page 4…ication Name: Catheter, Conduction, Anesthetic (21 CFR 868.5120, product code – BSO) Predicate Device B. BRAUN MEDICAL, INC. - PERIFIX CATHETER AND CONTIPLEX CATHETER, K042488 Device Description The Medline Epidural Catheter is a single use device made of flexible, nylon tubing which is sold as sterile… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 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.
- K801912Arrow Positive Placement Con/Epidural anArrow Intl., Inc. · 1980 · 4 generations back · ◆ in the 1980 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- 2 of the 15 ancestors have a recall of any class; 1 has a Class I recall.
- 5 other devices also cite its predicate K042488.
How does its category compare?
All BSO devicesBSO Catheter, Conduction, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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 Epidural Catheter is indicated for the injection of local anesthetics into the epidural space for
patients over 22 lbs. (10kgs.), for a duration of use of up to 72 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150731 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150731: Medline 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/K150731
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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