510(k) · Cleared
ClearedSpring-Wound Epidural Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micor, Inc. · BSO Catheter, Conduction, Anesthetic
Cleared on Oct 28, 1999 as substantially equivalent to K981329 (Epimed International, Inc., 1998) and 1 other predicate after a 148-day review. Its family tree reaches back 1 generation to 1989. 4 later devices descend from it.
- Decided
- Oct 28, 1999
- Review
- 148 days
- Class
- Class II
- Product code
- BSO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K885278 (1989). 2 ancestors in all. 4 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK885278 Epidural Anesthesia TrayPreferred Medical Products · 1989
- This deviceK991879 Spring-Wound Epidural CatheterMicor, Inc. · 1999
- Descendant · cites it directly · 1 of its ownK031600 Conduction CatheterMicor, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK231242 Perifix FX Catheter; Contiplex FX CatheterB.Braun Medical, Inc. · 2023
- Descendant · 2 generations on · 0 of its ownK060119 Mckinley Saturation CatheterMckinley Medical, LLC · 2006
- Descendant · cites it directly · 0 of its ownK050557 Amt NanocathAmerican Medical Technologies, Inc. · 2005
Most influential descendants
Showing 4 of 4 · See all- K031600Conduction CatheterMicor, Inc. · 2003 · cites it directly1descendant
- K231242Perifix FX Catheter; Contiplex FX CatheterB.Braun Medical, Inc. · 2023 · cites it directly0descendants
- K060119Mckinley Saturation CatheterMckinley Medical, LLC · 2006 · 2 generations on0descendants
- K050557Amt NanocathAmerican Medical Technologies, Inc. · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K885278 | Epidural Anesthesia Tray | Preferred Medical Products | 1989 | — |
| 0 (this device) | K991879 | Spring-Wound Epidural Catheter | Micor, Inc. | 1999 | — |
| +1 | K031600 | Conduction Catheter | Micor, Inc. | 2003 | — |
| +1 | K231242 | Perifix FX Catheter; Contiplex FX Catheter | B.Braun Medical, Inc. | 2023 | — |
| +2 | K060119 | Mckinley Saturation Catheter | Mckinley Medical, LLC | 2006 | — |
| +1 | K050557 | Amt Nanocath | American Medical Technologies, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2023 | 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.
Planning a device in BSO? 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 |
|---|---|---|---|
| * | K981329 | Feth-R-KathSummary page 1…on No.: 21 CFR 868.5120 Predicate Device 3.1 Arrow International, Inc. FlexTip Plus® Epidural Catheter 3.2 Epimed International, Inc. Feth-R-Kath® Epidural Catheters (K981329) 3.3 Preferred Medical Products Epidural Catheter (K885278) Product Description/Function 4.1 Description This catheter exhibit… | 1998 |
| * | K885278 | Epidural Anesthesia TraySummary page 1…tional, Inc. FlexTip Plus® Epidural Catheter 3.2 Epimed International, Inc. Feth-R-Kath® Epidural Catheters (K981329) 3.3 Preferred Medical Products Epidural Catheter (K885278) Product Description/Function 4.1 Description This catheter exhibits the same design and performance characteristics as the Arr… | 1989 |
| * | — | Arrow International, Inc. FlexTip Plus® Epidural Catheter Named without a submission number |
What descends from it? (4)
3 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 BSO devicesBSO Catheter, Conduction, Anesthetic: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Spring-Wound Epidiral Catheter is intended for administration of local anesthetic agents into the epidural space to provide continuous epidural or caudal anesthesia. Micor recommends that the catheter be removed or replaced every 72 hours.
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/K991879 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991879: Spring-Wound 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/K991879
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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