510(k) · Cleared
ClearedPerifix Safety Epidural Needles
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
B.Braun Medical, Inc. · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Jan 25, 2002 as substantially equivalent to K813179 (Burron Medical Products, Inc., 1981) and 1 other predicate after an 81-day review. Its family tree reaches back 1 generation to 1981. 5 later devices descend from it.
- Decided
- Jan 25, 2002
- Review
- 81 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K813179 (1981). 2 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK813179 Perican, Epidural CannulaBurron Medical Products, Inc. · 1981
- This deviceK013610 Perifix Safety Epidural NeedlesB.Braun Medical, Inc. · 2002
- Descendant · cites it directly · 3 of its ownK043500 Functional Anaesthetic Discography (Fad) System, Including Fad…Innospine, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 2 of its ownK061210 Functional Anaesthetic Discography (Fad) Catheter System, Model D01A…Kyphon, Inc. · 2006
- Descendant · 2 generations on · 1 of its ownK063071 Discyphor Catheter System, Model D01A; Discyphor Introducer Needle…Kyphon, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK073516 Discyphor Direct Catheter System, Discyphor Direct Needles, Long…Kyphon, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK032981 Sppro Esp, Models Esp 603-18-05, Esp 603-18-09Invamed Technologies, Inc. · 2004
Most influential descendants
Showing 5 of 5 · See all- K043500Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad…Innospine, Inc. · 2005 · cites it directly3descendants
- K061210Functional Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer…Kyphon, Inc. · 2006 · 2 generations on2descendants
- K063071Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01BKyphon, Inc. · 2007 · 2 generations on1descendant
- K073516Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor Direct…Kyphon, Inc. · 2008 · 2 generations on0descendants
- K032981Sppro Esp, Models Esp 603-18-05, Esp 603-18-09Invamed Technologies, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K813179 | Perican, Epidural Cannula | Burron Medical Products, Inc. | 1981 | — |
| 0 (this device) | K013610 | Perifix Safety Epidural Needles | B.Braun Medical, Inc. | 2002 | — |
| +1 | K043500 | Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit… | Innospine, Inc. | 2005 | 1 |
| +2 | K061210 | Functional Anaesthetic Discography (Fad) Catheter System, Model D01A… | Kyphon, Inc. | 2006 | — |
| +2 | K063071 | Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01B | Kyphon, Inc. | 2007 | — |
| +2 | K073516 | Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor… | Kyphon, Inc. | 2008 | — |
| +1 | K032981 | Sppro Esp, Models Esp 603-18-05, Esp 603-18-09 | Invamed Technologies, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 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 BSP? 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 BSP device
- #1 K241954 SonoBlock; SonoBlock IIscore 11.0 · 1 generation · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K813179 | Perican, Epidural CannulaSummary page 1…afety Epidural Cannula Class II, 21 CFR 868.5150: Anesthesia conduction needle and 868.5140: Anesthesia Conductin Kit . B. Braun Medical Inc. Perican Epidural Cannula, K813179 B. Braun Medical Inc. Perifix Set for Epidural Anesthesia Tuohy Needle / Catheter, K813186 B. Braun Medical Inc. Introcan Safety… | 1981 |
| * | K813186 | Perfix Set for Epidural Anesthesia W/TuoSummary page 1…: Anesthesia Conductin Kit . B. Braun Medical Inc. Perican Epidural Cannula, K813179 B. Braun Medical Inc. Perifix Set for Epidural Anesthesia Tuohy Needle / Catheter, K813186 B. Braun Medical Inc. Introcan Safety [V Catheter, K982805. The Perifix® Safety Epidural Needle will be available in a 17 Gauge… | 1981 |
| † | K982805 | Introcan Safety IV Catheter | 1999 |
What descends from it? (5)
2 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?
- None of the 2 ancestors has a recall.
- Of its descendants, K043500 (Innospine, Inc., 2005) has gone furthest, with 3 descendants of its own.
How does its category compare?
All BSP devicesBSP Needle, Conduction, Anesthetic (W/Wo Introducer): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BSP
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · BSP
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · BSP
1in 2020
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · BSP
86in 2025
MAUDE reports naming product code BSP, 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 | 3 | 189 | 0 | 26 |
| 2008 | 8 | 127 | 0 | 24 |
| 2009 | 5 | 97 | 0 | 30 |
| 2010 | 3 | 79 | 0 | 49 |
| 2011 | 3 | 114 | 0 | 33 |
| 2012 | 3 | 148 | 0 | 20 |
| 2013 | 2 | — | 0 | 32 |
| 2014 | 2 | — | 0 | 41 |
| 2015 | 2 | — | 0 | 38 |
| 2016 | 6 | 268 | 1 | 152 |
| 2017 | 4 | 186 | 0 | 34 |
| 2018 | 8 | 241 | 0 | 69 |
| 2019 | 2 | — | 1 | 86 |
| 2020 | 3 | 269 | 1 | 78 |
| 2021 | 3 | 265 | 0 | 52 |
| 2022 | 2 | — | 0 | 84 |
| 2023 | 0 | — | 0 | 75 |
| 2024 | 3 | 70 | 0 | 66 |
| 2025 | 4 | 170 | 0 | 86 |
| 2026 | 0 | — | 1 (1) | — |
What is it indicated for?
An active needle stick prevention device used by physicians to access the epidural space for the purpose of delivering an anesthetic and/or therapeutic agent or to facilitate placement of an epidural catheter. The needle can be used for single dose administration or in conjunction with the epidural catheter for continuous administration.
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/K013610 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013610: Perifix Safety Epidural Needles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013610
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026