510(k) · Cleared

Cleared

Smith & Nephew CDS System

K081491510(k) SpecialCleared Jun 19, 200822-day reviewClass II21 CFR 892.1650

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

Smith & Nephew, Inc. · JAA System, X-Ray, Fluoroscopic, Image-Intensified

Cleared on Jun 19, 2008 as substantially equivalent to K051136 (Smith & Nephew, Inc., 2005) after a 22-day review. Its family tree reaches back 2 generations to 1996.

Decided: Jun 19, 2008
Review: 22 days
Class: Class II
Product code: JAA
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K960082 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK960082 Discography KitSpinal Specialties, Inc. · 1996
1 generation backK051136 Smith & Nephew CDS SystemSmith & Nephew, Inc. · 2005
This deviceK081491 Smith & Nephew CDS SystemSmith & Nephew, Inc. · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K960082	Discography Kit	Spinal Specialties, Inc.	1996	—
−1	K051136	Smith & Nephew CDS System	Smith & Nephew, Inc.	2005	—
0 (this device)	K081491	Smith & Nephew CDS System	Smith & Nephew, Inc.	2008	—

FIG. 1 — Lineage of K081491, 1996–2008Source: 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.

Planning a device in JAA? 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 JAA device

#1 K253103 Nexus DRF Digital X-ray Imaging Systemscore 13.2 · 7 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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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	Applicant	Decided	Recalls
*	K051136	Smith & Nephew CDS System Summary page 1 …dures such as discography. Technological Characteristics: The proposed Smith & Nephew CDS System is substantially equivalent to the predicate Smith & Nephew CDS System (K051136). The proposed CDS System remote control underwent firmware and hardware. modifications to improve its performance and reliabilit…	Smith & Nephew, Inc.	2005	—

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 12 years and passes through 2 companies; a new generation was cleared every 9.3 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All JAA devices

JAA System, X-Ray, Fluoroscopic, Image-Intensified: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · JAA

2in 2025

2007high 6 (2008) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAA

89in 2024

2007high 276 (2014) · low 18 (2008)2026

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

Recalls per year · JAA

4in 2025

2007high 35 (2007) · low 1 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · JAA

33in 2025

2007high 14,000 (2011) · low 25 (2024)2025

MAUDE reports naming product code JAA, 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	1	—	35	9,517
2008	6	18	21	9,484
2009	0	—	18	12,040
2010	1	—	6	5,803
2011	4	48	7	14,000
2012	1	—	2	11,684
2013	6	129	3	13,706
2014	6	276	1	10,265
2015	3	197	1	2,922
2016	2	—	7	35
2017	1	—	3	56
2018	3	30	1	36
2019	6	49	2	49
2020	4	39	2	39
2021	6	104	2	35
2022	1	—	5	34
2023	2	—	9	41
2024	3	89	2	25
2025	2	—	4	33
2026	1	—	0	—

What is it indicated for?

The Smith & Nephew CDS System is intended to dispense and monitor the pressure of fluids during spinal procedures such as discography.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K081491 · printed Nov 4, 2026

Cite this page

510(k) Report. “K081491: Smith & Nephew CDS System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081491

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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