510(k) · Cleared

Cleared

Discography Kit

K960082510(k) TraditionalCleared Mar 21, 199670-day reviewClass II21 CFR 892.1730

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

Spinal Specialties, Inc. · IZG System, X-Ray, Photofluorographic

Cleared on Mar 21, 1996 after a 70-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 9 later devices descend from it.

Decided: Mar 21, 1996
Review: 70 days
Class: Class II
Product code: IZG
Recalls: None
Predicates: 0

9 later devices descend from it, 3 citing it directly.

This deviceK960082 Discography KitSpinal Specialties, Inc. · 1996
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 · cites it directly · 2 of its ownK033739 Physician Industries' Durameter SyringePhysician Industries, Inc. · 2004
Descendant · 2 generations on · 1 of its ownK063071 Discyphor Catheter System, Model D01A; Discyphor Introducer Needle…Kyphon, Inc. · 2007
Descendant · cites it directly · 1 of its ownK051136 Smith & Nephew CDS SystemSmith & Nephew, Inc. · 2005

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2004high 3 (2005) · low 0 (2009)2026

Most influential descendants

Showing 5 of 9 · 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
K033739Physician Industries' Durameter SyringePhysician Industries, Inc. · 2004 · cites it directly2descendants
K063071Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01BKyphon, Inc. · 2007 · 2 generations on1descendant
K051136Smith & Nephew CDS SystemSmith & Nephew, Inc. · 2005 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K960082	Discography Kit	Spinal Specialties, Inc.	1996	—
+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	—
+1	K033739	Physician Industries' Durameter Syringe	Physician Industries, Inc.	2004	—
+2	K063071	Discyphor Catheter System, Model D01A; Discyphor Introducer Needle, Model D01B	Kyphon, Inc.	2007	—
+1	K051136	Smith & Nephew CDS System	Smith & Nephew, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	3	0
2006	1	0
2007	1	0
2008	2	0
2011	1	0

FIG. 1 — Lineage of K960082, 1996–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IZG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (9)

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

Number	Device	Applicant	Decided	Descendants
K043500	Functional Anaesthetic Discography (Fad) System, Including Fad Catheter Kit and Fad…	Innospine, Inc.	2005	3
K033739	Physician Industries' Durameter Syringe	Physician Industries, Inc.	2004	2
K051136	Smith & Nephew CDS System	Smith & Nephew, Inc.	2005	1

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?

Of its descendants, K043500 (Innospine, Inc., 2005) has gone furthest, with 3 descendants of its own.

How does its category compare?

All IZG devices

IZG System, X-Ray, Photofluorographic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IZG

FDA has decided no IZG device since 2007.

Median 510(k) review, days · IZG

Too few IZG 510(k)s in any year since 2007 to give a median.

Recalls per year · IZG

No recall names IZG since 2007.

Adverse event reports per year · IZG

1in 2008

2007high 1 (2008) · low 0 (2007)2025

MAUDE reports naming product code IZG, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	1
2009	—	0
2010	—	0
2011	—	0
2012	—	0
2013	—	0
2014	—	0
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

https://510kreport.com/device/K960082 · printed Nov 6, 2026

Cite this page

510(k) Report. “K960082: Discography Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K960082

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026