510(k) · Cleared

Recalled · 2006

Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad Introducer Needle

K043500510(k) TraditionalCleared Apr 15, 2005116-day reviewClass II21 CFR 868.5150Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Innospine, Inc. · BSP Needle, Conduction, Anesthetic (W/Wo Introducer)

Cleared on Apr 15, 2005 as substantially equivalent to K960082 (Spinal Specialties, Inc., 1996) and 5 other predicates after a 116-day review. Its family tree reaches back 6 generations to 1990. 3 of the 33 devices in its family, counting itself, have a Class I recall. 3 later devices descend from it. It has been recalled once.

Decided: Apr 15, 2005
Review: 116 days
Class: Class II
Product code: BSP
Recalls: 1
Predicates: 6

Its longest line of descent runs back 6 generations to K896422 (1990). 29 ancestors in all, the oldest K801912 (1980). 3 later devices descend from it, 3 citing it directly. 3 of the 33 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 6 generations backK896422 Burron Ambulatory Drug Delivery SystemBurron Medical, Inc. · 1990
5 generations backK980558 Painbuster Infusion SystemI-Flow Corp. · 1998
4 generations backK982946 Painbuster Infusion KitI-Flow Corp. · 1998
3 generations backK984502 Nerve Block Infusion KitI-Flow Corp. · 1999
2 generations backK030830 B. Braun Nerve Block CatheterB.Braun Medical, Inc. · 2003
1 generation backK042488 Perifix Catheter and Contiplex CatheterB.Braun Medical, Inc. · 2004
This deviceK043500 Functional Anaesthetic Discography (Fad) System, Including Fad…Innospine, Inc. · 2005
Descendant · cites it directly · 2 of its ownK061210 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

K911202 Atraumatic Standard Sprotte Needle2 generations back · 1992
K911260 Atraumatic Standard Sprotte Needle2 generations back · 1991
K801912 Arrow Positive Placement Con/Epidural an4 generations back · 1980

Most influential descendants

Showing 3 of 3 · See all

K061210Functional Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer…Kyphon, Inc. · 2006 · cites it directly2descendants
K063071Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01BKyphon, Inc. · 2007 · cites it directly1descendant
K073516Discyphor Direct Catheter System, Discyphor Direct Needles, Long, Discyphor Direct…Kyphon, Inc. · 2008 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K896422	Burron Ambulatory Drug Delivery System	Burron Medical, Inc.	1990	—
−5	K980558	Painbuster Infusion System	I-Flow Corp.	1998	—
−4	K982946	Painbuster Infusion Kit	I-Flow Corp.	1998	—
−3	K984502	Nerve Block Infusion Kit	I-Flow Corp.	1999	—
−2	K030830	B. Braun Nerve Block Catheter	B.Braun Medical, Inc.	2003	—
−1	K042488	Perifix Catheter and Contiplex Catheter	B.Braun Medical, Inc.	2004	—
0 (this device)	K043500	Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit…	Innospine, Inc.	2005	—
+1	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
2006	1	0
2007	1	0
2008	1	0

FIG. 1 — Lineage of K043500, 1990–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (6)

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	Applicant	Decided	Recalls
*	K960082	Discography Kit Summary page 2 …BMISSION Generic/Common Name: Anesthesia conduction catheter Anesthesia conduction needle PREDICATE DEVICES FAD Catheter Kit: * Spinal Specialties Discography Kit, K960082, cleared 3/21/96 * Epimed Versa-Kath Epidural Catheter, K023140, cleared 8/15/03 * Braun Perifix Catheter, K042488, cleared 9/30/…	Spinal Specialties, Inc.	1996	—
*	K023140	Versa-Kath Epidural Catheter, Model 156-2124 Summary page 2 …Anesthesia conduction needle PREDICATE DEVICES FAD Catheter Kit: * Spinal Specialties Discography Kit, K960082, cleared 3/21/96 * Epimed Versa-Kath Epidural Catheter, K023140, cleared 8/15/03 * Braun Perifix Catheter, K042488, cleared 9/30/04 FAD Introducer Needle: * Braun Perifix Safety Epidural Needl…	Epimed International, Inc.	2003	2
*	K042488	Perifix Catheter and Contiplex Catheter Summary page 2 …AD Catheter Kit: * Spinal Specialties Discography Kit, K960082, cleared 3/21/96 * Epimed Versa-Kath Epidural Catheter, K023140, cleared 8/15/03 * Braun Perifix Catheter, K042488, cleared 9/30/04 FAD Introducer Needle: * Braun Perifix Safety Epidural Needle, K013610, cleared 1/25/02 * Epimed Quincke Spinal…	B.Braun Medical, Inc.	2004	—
*	K013610	Perifix Safety Epidural Needles Summary page 2 …Versa-Kath Epidural Catheter, K023140, cleared 8/15/03 * Braun Perifix Catheter, K042488, cleared 9/30/04 FAD Introducer Needle: * Braun Perifix Safety Epidural Needle, K013610, cleared 1/25/02 * Epimed Quincke Spinal Needle, K022029, cleared 7/30/02 * Pajunk Touhy Needles, K040965, cleared 9/7/04 INTEND…	B.Braun Medical, Inc.	2002	—
*	K022029	Quincke Spinal Needle Summary page 2 …Braun Perifix Catheter, K042488, cleared 9/30/04 FAD Introducer Needle: * Braun Perifix Safety Epidural Needle, K013610, cleared 1/25/02 * Epimed Quincke Spinal Needle, K022029, cleared 7/30/02 * Pajunk Touhy Needles, K040965, cleared 9/7/04 INTENDED USE The Functional Anaesthetic Discography (FAD) Syst…	Epimed International, Inc.	2002	—
*	K040965	Pajunk Tuohy Needles, Quincke Needles, Chiba Needles & Crawford Needles Summary page 2 …FAD Introducer Needle: * Braun Perifix Safety Epidural Needle, K013610, cleared 1/25/02 * Epimed Quincke Spinal Needle, K022029, cleared 7/30/02 * Pajunk Touhy Needles, K040965, cleared 9/7/04 INTENDED USE The Functional Anaesthetic Discography (FAD) System is intended for use in delivering either a sin…	Pajunk GmbH	2004	—

Also cleared against K960082: 2 other devices →

What descends from it? (3)

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K061210	Functional Anaesthetic Discography (Fad) Catheter System, Model D01A ; Introducer…	Kyphon, Inc.	2006	2
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 Direct…	Kyphon, Inc.	2008	0

Has anything in its family been recalled? (3 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Apr 25, 2006	Not classified	Z-0948-2008	Labeling design	Guidewire Breakages: during the Functional Anaesthetic Discography (F.A.D.) procedure.

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 · 2 generations back · ◆ in the 1992 ancestors bar of FIG. 11 Class I recall
K911260Atraumatic Standard Sprotte NeedlePajunk GmbH · 1991 · 2 generations back · ◆ in the 1991 ancestors bar of FIG. 11 Class I recall
K801912Arrow Positive Placement Con/Epidural anArrow Intl., Inc. · 1980 · 4 generations back · ◆ in the 1980 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
6 of the 29 ancestors have a recall of any class; 3 have a Class I recall.
Of its descendants, K061210 (Kyphon, Inc., 2006) has gone furthest, with 2 descendants of its own.
2 other devices also cite its predicate K960082.

How does its category compare?

All BSP devices

BSP 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

2007high 8 (2008) · low 0 (2023)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · BSP

170in 2025

2007high 269 (2020) · low 70 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · BSP

1in 2020

2007high 1 (2016) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · BSP

86in 2025

2007high 152 (2016) · low 20 (2012)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 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/K043500 · printed Nov 4, 2026

Cite this page

510(k) Report. “K043500: Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad Introducer Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043500

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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