510(k) · Cleared
ClearedFunctional Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer Needle, Model D01B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kyphon, Inc. · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)
Cleared on Jun 27, 2006 as substantially equivalent to K043500 (Innospine, Inc., 2005) after a 57-day review. Its family tree reaches back 7 generations to 1990. 3 of the 33 devices in its family, counting itself, have a Class I recall. 2 later devices descend from it.
- Decided
- Jun 27, 2006
- Review
- 57 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K896422 (1990). 30 ancestors in all, the oldest K801912 (1980). 2 later devices descend from it, 2 citing it directly. 3 of the 33 devices in this family, counting this one, have a Class I recall.
- Root · 7 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 6 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
- 5 generations backK982946 Painbuster Infusion KitI-Flow Corp. · 1998
- 4 generations backK984502 Nerve Block Infusion KitI-Flow Corp. · 1999
- 3 generations backK030830 B. Braun Nerve Block CatheterB.Braun Medical, Inc. · 2003
- 2 generations backK042488 Perifix Catheter and Contiplex CatheterB.Braun Medical, Inc. · 2004
- 1 generation backK043500 Functional Anaesthetic Discography (Fad) System, Including Fad…Innospine, Inc. · 2005 · Recalled
- This deviceK061210 Functional Anaesthetic Discography (Fad) Catheter System, Model D01A…Kyphon, Inc. · 2006
- Descendant · cites it directly · 1 of its ownK063071 Discyphor Catheter System, Model D01A; Discyphor Introducer Needle…Kyphon, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK073516 Discyphor Direct Catheter System, Discyphor Direct Needles, Long…Kyphon, Inc. · 2008
Class I recalls in this family
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| −6 | K980558 | Painbuster Infusion System | I-Flow Corp. | 1998 | — |
| −5 | K982946 | Painbuster Infusion Kit | I-Flow Corp. | 1998 | — |
| −4 | K984502 | Nerve Block Infusion Kit | I-Flow Corp. | 1999 | — |
| −3 | K030830 | B. Braun Nerve Block Catheter | B.Braun Medical, Inc. | 2003 | — |
| −2 | K042488 | Perifix Catheter and Contiplex Catheter | B.Braun Medical, Inc. | 2004 | — |
| −1 | K043500 | Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit… | Innospine, Inc. | 2005 | 1 |
| 0 (this device) | K061210 | Functional Anaesthetic Discography (Fad) Catheter System, Model D01A… | Kyphon, Inc. | 2006 | — |
| +1 | K063071 | Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01B | Kyphon, Inc. | 2007 | — |
| +1 | K073516 | Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor… | Kyphon, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 1 |
| 1981 | 2 | 0 |
| 1984 | 1 | 0 |
| 1991 | 1 | 1 |
| 1992 | 2 | 1 |
| 1993 | 3 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
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 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? (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 |
|---|---|---|---|
| * | K043500 | Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad…Summary page 1…: 1221 Crossman Avenue Sunnyvale, CA 94089 Phone: (408) 548-5421 eDevice(s): K043500, Functional Anaesthetic Discography (F.A.D.) Catheter System, cleared on April 15, 2005. Intended… | 2005 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 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.
- K911202Atraumatic Standard Sprotte NeedlePajunk GmbH · 1992 · 3 generations back · ◆ in the 1992 ancestors bar of FIG. 11 Class I recall
- K911260Atraumatic Standard Sprotte NeedlePajunk GmbH · 1991 · 3 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
- K801912Arrow Positive Placement Con/Epidural anArrow Intl., Inc. · 1980 · 5 generations back · ◆ in the 1980 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 7 of the 30 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K063071 (Kyphon, Inc., 2007) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K043500.
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?
The Functional Anaesthetic Discography (FAD) Catheter System is intended for use in delivering either a single dose or continuous administration of a radiopaque contrast, local anaesthetics, and/or saline solution to the intradiscal space.
The Functional Anaesthetic Discography (FAD) Introducer Needle is intended for use to access the area adjacent to the intradiscal space for the purpose of facilitating placement of the FAD Catheter and Guidewire into the intradiscal space.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061210 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061210: Functional Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer Needle, Model D01B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061210
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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