510(k) · Cleared
Recalled · Class I · 2026Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve Block Catheter Kit/Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleflex, Inc. · BSO Catheter, Conduction, Anesthetic
Cleared on Mar 27, 2015 as substantially equivalent to K103658 (Teleflex, Inc., 2012) after a 436-day review. Its family tree reaches back 2 generations to 1989. 3 of the 4 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled 9 times, including a Class I recall.
- Decided
- Mar 27, 2015
- Review
- 436 days
- Class
- Class II
- Product code
- BSO
- Recalls
- 9 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 2 generations to K884552 (1989). 1 later device descends from it, 1 citing it directly. 3 of the 4 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK884552 Continuous Epidural Anesthesia Kit W/Poly CatheterArrow Intl., Inc. · 1989 · Recalled (Class I)
- 1 generation backK103658 Flextip Plus Closed Tip Epidural CatherterTeleflex, Inc. · 2012 · Recalled (Class I)
- This deviceK140110 Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve…Teleflex, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK181782 Medline Reinforced Epidural CatheterMedline Industries, Inc. · 2019
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K181782Medline Reinforced Epidural CatheterMedline Industries, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K884552 | Continuous Epidural Anesthesia Kit W/Poly Catheter | Arrow Intl., Inc. | 1989 | Class I |
| −1 | K103658 | Flextip Plus Closed Tip Epidural Catherter | Teleflex, Inc. | 2012 | Class I |
| 0 (this device) | K140110 | Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve Block… | Teleflex, Inc. | 2015 | — |
| +1 | K181782 | Medline Reinforced Epidural Catheter | Medline Industries, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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.
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 |
|---|---|---|---|
| * | K103658 | Flextip Plus Closed Tip Epidural CatherterSummary page 5…CFR 868.5120 Class 2 Kit: CAZ – Anesthesia Conduction Kit 21 CFR 868.5140 Class 2 Predicate Device 1. FlexTip Plus Epidural Catheter - K103658 Modification and Changes to Predicate The purpose of this traditional 510(k) is to update the MR Conditional statements in the… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K181782 | Medline Reinforced Epidural Catheter | 2019 | 0 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 21, 2026 | Class I | Z-2371-2026 | Nonconforming Material/Component | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a… |
| Mar 11, 2026 | Class II | Z-1913-2026 | Process control | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured |
| May 8, 2020 | Class II | Z-2288-2020 | Under Investigation by firm | Nine complaints reported that the rotatable collar on the filter had detached, causing a leak. |
| Jan 15, 2020 | Class II | Z-1174-2020 | Other | There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch. |
| Jan 15, 2020 | Class II | Z-1177-2020 | Other | There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch. |
| Jan 15, 2020 | Class II | Z-1172-2020 | Other | There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch. |
| Dec 20, 2019 | Class II | Z-1237-2020 | Incorrect or no expiration date | Product lidstock contains the incorrect expiration date for the product |
| Dec 20, 2019 | Class II | Z-1238-2020 | Incorrect or no expiration date | Product lidstock contains the incorrect expiration date for the product |
| Dec 20, 2019 | Class II | Z-1236-2020 | Incorrect or no expiration date | Product lidstock contains the incorrect expiration date for the product |
The 5 latest of 9 recalls; the web page lists all.
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.
What does this lineage say?
- The line of descent spans 26 years and passes through 2 companies; a new generation was cleared every 23.2 years on median.
- 2 of the 2 ancestors have a recall of any class; 2 have a Class I recall.
- Of its descendants, K181782 (Medline Industries, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K103658.
How does its category compare?
All BSO devicesBSO Catheter, Conduction, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Arrow Epidural Catheter permits access to the epidural space for the administration of epidural anesthetic. The epidural catheter is intended for use up to 72 hours.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140110 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140110: Flextip Plus Epidural Catheter;Flexblock Continous Peripheral Nerve Block Catheter Kit/Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140110
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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