510(k) · Cleared
ClearedIntraop Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
I-Flow Corp. · MEB Pump, Infusion, Elastomeric
Cleared on Oct 25, 1999 as substantially equivalent to K840202 (Aries Medical, Inc., 1984) and 1 other predicate after a 175-day review. Its family tree reaches back 1 generation to 1981. 31 later devices descend from it.
- Decided
- Oct 25, 1999
- Review
- 175 days
- Class
- Class II
- Product code
- MEB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K813186 (1981). 2 ancestors in all. 31 later devices descend from it, 5 citing it directly.
- Root · 1 generation backK813186 Perfix Set for Epidural Anesthesia W/TuoBurron Medical Products, Inc. · 1981
- This deviceK991543 Intraop CatheterI-Flow Corp. · 1999
- Descendant · cites it directly · 18 of its ownK994374 Soaker CatheterI-Flow Corp. · 2000
- Descendant · cites it directly · 12 of its ownK022869 Soaker CatheterI-Flow Corp. · 2002
- Descendant · cites it directly · 11 of its ownK043456 Modification to Soaker CatheterI-Flow Corp. · 2005
- Descendant · cites it directly · 10 of its ownK030830 B. Braun Nerve Block CatheterB.Braun Medical, Inc. · 2003
- Descendant · 2 generations on · 9 of its ownK042488 Perifix Catheter and Contiplex CatheterB.Braun Medical, Inc. · 2004
Showing 5 of 31 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 31 · See all- K994374Soaker CatheterI-Flow Corp. · 2000 · cites it directly18descendants
- K022869Soaker CatheterI-Flow Corp. · 2002 · cites it directly12descendants
- K043456Modification to Soaker CatheterI-Flow Corp. · 2005 · cites it directly11descendants
- K030830B. Braun Nerve Block CatheterB.Braun Medical, Inc. · 2003 · cites it directly10descendants
- K042488Perifix Catheter and Contiplex CatheterB.Braun Medical, Inc. · 2004 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K813186 | Perfix Set for Epidural Anesthesia W/Tuo | Burron Medical Products, Inc. | 1981 | — |
| 0 (this device) | K991543 | Intraop Catheter | I-Flow Corp. | 1999 | — |
| +1 | K994374 | Soaker Catheter | I-Flow Corp. | 2000 | — |
| +1 | K022869 | Soaker Catheter | I-Flow Corp. | 2002 | — |
| +1 | K043456 | Modification to Soaker Catheter | I-Flow Corp. | 2005 | — |
| +1 | K030830 | B. Braun Nerve Block Catheter | B.Braun Medical, Inc. | 2003 | — |
| +2 | K042488 | Perifix Catheter and Contiplex Catheter | B.Braun Medical, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 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 MEB? 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 MEB device
- #1 K250234 SMARTeZ™ Elastomeric Infusion Pump (RS series)score 14.5 · 12 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 |
|---|---|---|---|
| * | K840202 | Epidural CatheterSummary page 1…0 GENERAL INFORMATION 1.1 Statement of Equivalence 1.1.1 1.1.2 The Intra Op Catheter is substantially equivalent to the (1) Teleflex Medical (TFX) Epidural Catheter (K840202, originally submitted by Aries) (2) the B. Braun Perifix Set (K813186) and (3) the Epimed Internation FETH-R_KATH catheter. The… | 1984 |
| * | K813186 | Perfix Set for Epidural Anesthesia W/TuoSummary page 1…Intra Op Catheter is substantially equivalent to the (1) Teleflex Medical (TFX) Epidural Catheter (K840202, originally submitted by Aries) (2) the B. Braun Perifix Set (K813186) and (3) the Epimed Internation FETH-R_KATH catheter. The Intra Op Catheter package may include components that are legally mark… | 1981 |
| * | — | Epimed Internation FETH-R_KATH catheter Named without a submission number |
What descends from it? (31)
See all 315 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?
How does its category compare?
All MEB devicesMEB Pump, Infusion, Elastomeric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MEB
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MEB
42in 2007
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MEB
17in 2018
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · MEB
1,408in 2025
MAUDE reports naming product code MEB, 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 | 5 | 42 | 1 | 110 |
| 2008 | 2 | — | 3 | 444 |
| 2009 | 1 | — | 48 | 798 |
| 2010 | 0 | — | 2 | 1,827 |
| 2011 | 0 | — | 8 (1) | 2,265 |
| 2012 | 0 | — | 0 | 1,976 |
| 2013 | 1 | — | 2 (1) | 1,956 |
| 2014 | 1 | — | 0 | 2,695 |
| 2015 | 0 | — | 0 | 2,980 |
| 2016 | 1 | — | 0 | 2,147 |
| 2017 | 0 | — | 0 | 1,653 |
| 2018 | 0 | — | 17 | 1,473 |
| 2019 | 1 | — | 0 | 974 |
| 2020 | 0 | — | 0 | 2,732 |
| 2021 | 0 | — | 0 | 1,802 |
| 2022 | 0 | — | 0 | 1,288 |
| 2023 | 0 | — | 0 | 1,248 |
| 2024 | 2 | — | 0 | 1,424 |
| 2025 | 0 | — | 0 | 1,408 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Intra Op Catheter is intended to provide continuous or intermittent delivery of local anasthetics or narcotics to surgical wound sites and nerve trunks outside of the epidural space.
Routes of administration may be either, intraoperative, intramuscular, subcutaneous or percutaneous.
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/K991543 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991543: Intraop Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991543
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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