510(k) · Cleared
ClearedDiscyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor Direct Needles, Regular
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 Feb 21, 2008 as substantially equivalent to K063071 (Kyphon, Inc., 2007) and 2 other predicates after a 69-day review. Its family tree reaches back 9 generations to 1990. 3 of the 33 devices in its family, counting itself, have a Class I recall.
- Decided
- Feb 21, 2008
- Review
- 69 days
- Class
- Class II
- Product code
- BSP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K896422 (1990). 32 ancestors in all, the oldest K801912 (1980). No later device cites it as a predicate yet. 3 of the 33 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 5 generations between
- 3 generations backK043500 Functional Anaesthetic Discography (Fad) System, Including Fad…Innospine, Inc. · 2005 · Recalled
- 2 generations backK061210 Functional Anaesthetic Discography (Fad) Catheter System, Model D01A…Kyphon, Inc. · 2006
- 1 generation backK063071 Discyphor Catheter System, Model D01A; Discyphor Introducer Needle…Kyphon, Inc. · 2007
- This deviceK073516 Discyphor Direct Catheter System, Discyphor Direct Needles, Long…Kyphon, Inc. · 2008
Show all 9 generations
- Root · 9 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
- 8 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
- 7 generations backK982946 Painbuster Infusion KitI-Flow Corp. · 1998
- 6 generations backK984502 Nerve Block Infusion KitI-Flow Corp. · 1999
- 5 generations backK030830 B. Braun Nerve Block CatheterB.Braun Medical, Inc. · 2003
- 4 generations backK042488 Perifix Catheter and Contiplex CatheterB.Braun Medical, Inc. · 2004
- 3 generations backK043500 Functional Anaesthetic Discography (Fad) System, Including Fad…Innospine, Inc. · 2005 · Recalled
- 2 generations backK061210 Functional Anaesthetic Discography (Fad) Catheter System, Model D01A…Kyphon, Inc. · 2006
- 1 generation backK063071 Discyphor Catheter System, Model D01A; Discyphor Introducer Needle…Kyphon, Inc. · 2007
- This deviceK073516 Discyphor Direct Catheter System, Discyphor Direct Needles, Long…Kyphon, Inc. · 2008
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K896422 | Burron Ambulatory Drug Delivery System | Burron Medical, Inc. | 1990 | — |
| −8 | K980558 | Painbuster Infusion System | I-Flow Corp. | 1998 | — |
| −7 | K982946 | Painbuster Infusion Kit | I-Flow Corp. | 1998 | — |
| −6 | K984502 | Nerve Block Infusion Kit | I-Flow Corp. | 1999 | — |
| −5 | K030830 | B. Braun Nerve Block Catheter | B.Braun Medical, Inc. | 2003 | — |
| −4 | K042488 | Perifix Catheter and Contiplex Catheter | B.Braun Medical, Inc. | 2004 | — |
| −3 | 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 | — |
| −1 | K063071 | Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01B | Kyphon, Inc. | 2007 | — |
| 0 (this device) | 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 |
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? (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 |
|---|---|---|---|
| * | K063071 | Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01BSummary page 1…airs Address: 1221 Crossman Avenue Sunnyvale, CA 94089 Phone: (408) 548-5235 Predicate K063071 (cleared on April 13, 2007): DiscyphorTM Catheter System Device(s):… | 2007 |
| * | K061210 | Functional Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer…Summary page 1…DiscyphorTM Introducer Needle DiscyphorTM Spinal Needle K061210, (cleared on June 27, 2006) Functional Anaesthetic Discography (F.A.D.) Catheter System.… | 2006 |
| * | K043500 | Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad…Summary page 1…K061210, (cleared on June 27, 2006) Functional Anaesthetic Discography (F.A.D.) Catheter System. K043500, (cleared on April 15, 2005) Functional Anaesthetic Discography (F.A.D.) Catheter System.… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 7 of the 32 ancestors have a recall of any class; 3 have a Class I recall.
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. 2008, this device’s year, is highlighted.
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 Kyphon Discyphor Direct™ Catheter System for the Functional Anaesthetic Discography™ Procedure, and its components, are intended for use in delivering either a single dose or continuous administration of radiopaque contrast, local anaesthetics, and/or saline solution to the intradiscal space. The Kyphon Discyphor Direct™ Outer Needle is intended for use to access the area adjacent to the intradiscal space for the purpose of facilitating sequential…
Read the full statement (167 words)
The Kyphon Discyphor Direct™ Catheter System for the Functional Anaesthetic Discography™ Procedure, and its components, are intended for use in delivering either a single dose or continuous administration of radiopaque contrast, local anaesthetics, and/or saline solution to the intradiscal space.
The Kyphon Discyphor Direct™ Outer Needle is intended for use to access the area adjacent to the intradiscal space for the purpose of facilitating sequential placement of the Discyphor Direct™ Inner Needle and Discyphor Direct™ Catheter into the intradiscal space. The Discyphor Direct™ Outer Needle is intended to be used only with the Discyphor Direct™ Catheter System.
The Kyphon Discyphor Direct™ Inner Needle is intended to access the nucleus of an intervertebral disc for the purpose of performing provocative discography and facilitating placement of the Discyphor Direct™ Catheter into the intradiscal space. The Discyphor Direct™ Inner Needle can be used to deliver contrast, antibiotic, and/or saline into an intervertebral disc. The Discyphor Direct™ Inner Needle is intended to be used only with the Discyphor Direct™ Catheter System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073516 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073516: Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor Direct Needles, Regular.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073516
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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