510(k) · Cleared
ClearedIO-Flex Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxano, Inc. · BSO Catheter, Conduction, Anesthetic
Cleared on Jan 19, 2011 as substantially equivalent to K063234 (I-Flow Corp., 2006) and 2 other predicates after a 132-day review. Its family tree reaches back 6 generations to 1990. 1 of the 18 devices in its family, counting itself, has a Class I recall.
- Decided
- Jan 19, 2011
- Review
- 132 days
- Class
- Class II
- Product code
- BSO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K896422 (1990). 17 ancestors in all, the oldest K801912 (1980). No later device cites it as a predicate yet. 1 of the 18 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 deviceK102594 IO-Flex CatheterBaxano, Inc. · 2011
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) | K102594 | IO-Flex Catheter | Baxano, Inc. | 2011 | — |
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 |
| 2000 | 1 | 0 |
| 2006 | 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? (3)
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 |
|---|---|---|---|
| * | K063234 | ON-Q IntroducersSummary page 1…ia Conduction Catheter Classification: Class 11 (21 CFR 868.5120) Product Code: BSO Predicate Devices: I-Flow Corporation, ON-Q Introducers (K063234) B.Braun, Regional Anesthesia Catheters (K042488) Axiom Medical, Inc., Multipur… | 2006 |
| * | K042488 | Perifix Catheter and Contiplex CatheterSummary page 1…) Product Code: BSO Predicate Devices: I-Flow Corporation, ON-Q Introducers (K063234) B.Braun, Regional Anesthesia Catheters (K042488) Axiom Medical, Inc., Multipurpose Wound Drain Catheter (K993592) Device Descr… | 2004 |
| * | K993592 | Axiom Multipurpose Wound DrainSummary page 1…B.Braun, Regional Anesthesia Catheters (K042488) Axiom Medical, Inc., Multipurpose Wound Drain Catheter (K993592) Device Description: The iO-Flex Catheter is comprised of two primary components: (1) Y-Adapter wi… | 2000 |
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 21 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- 2 of the 17 ancestors have a recall of any class; 1 has a Class I recall.
- 2 other devices also cite its predicate K063234.
How does its category compare?
All BSO devicesBSO Catheter, Conduction, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 iO-Flex Catheter is for continuous or intermittent preoperative, perioperative or post-operative delivery of local anesthetics and analgesics in the epidural space or near a nerve for regional anesthesia and pain management. The catheter may also be used perioperatively during open spinal procedures to irrigate, aspirate or inject a bolus of fluid or medication.
The iO-Flex Catheter is designed for use with the iO-Flex Wire.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102594 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102594: IO-Flex Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102594
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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