510(k) · Cleared

Cleared

The Wand

K992404510(k) TraditionalCleared Jun 6, 2000323-day reviewClass II21 CFR 880.5860

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

Cleared on Jun 6, 2000 as substantially equivalent to K961648 (Spintech, Inc., 1996) and 2 other predicates after a 323-day review. Its family tree reaches back 2 generations to 1996.

Decided: Jun 6, 2000
Review: 323 days
Class: Class II
Product code: FMF
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K961648 (1996). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK961648 The WandSpintech, Inc. · 1996
1 generation backK983105 CCS; Computer Controlled Syringe, Model #CCS-100, CCS; Cartridge…Dentsply Midwest · 1999
This deviceK992404 The WandSpintech, Inc. · 2000

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K961648	The Wand	Spintech, Inc.	1996	—
−1	K983105	CCS; Computer Controlled Syringe, Model #CCS-100, CCS; Cartridge Holder…	Dentsply Midwest	1999	—
0 (this device)	K992404	The Wand	Spintech, Inc.	2000	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1996	1	0

FIG. 1 — Lineage of K992404, 1996–2000Source: 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 FMF? 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 FMF device

#1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 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? (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	Applicant	Decided	Recalls
*	K961648	The Wand Summary page 1 …ls, principal of operation and intended use are the same as other marketed piston and cartridge syringes. The device is substantially equivalent to the Wand™ (Spintech, K961648); the Shifa syringe (Alshifa Medical; K962614); and the CCS Computer Controlled Syringe (CATCO; K983105). For injection of lidoc…	Spintech, Inc.	1996	—
*	K962614	Shifa Sterile Disposable Syringes Summary page 1 …e the same as other marketed piston and cartridge syringes. The device is substantially equivalent to the Wand™ (Spintech, K961648); the Shifa syringe (Alshifa Medical; K962614); and the CCS Computer Controlled Syringe (CATCO; K983105). For injection of lidocaine subcutaneously or intramuscularly for inf…	International Regulatory Consultants	1996	—
*	K983105	CCS; Computer Controlled Syringe, Model #CCS-100, CCS; Cartridge Holder (Replacements)… Summary page 1 …. The device is substantially equivalent to the Wand™ (Spintech, K961648); the Shifa syringe (Alshifa Medical; K962614); and the CCS Computer Controlled Syringe (CATCO; K983105). For injection of lidocaine subcutaneously or intramuscularly for infiltration and nerve block. seavice, & C D…	Dentsply Midwest	1999	—

Also cleared against K961648: 1 other device →

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 4 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
None of the 3 ancestors has a recall.
1 other device also cites its predicate K961648.

How does its category compare?

All FMF devices

FMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FMF

13in 2025

2007high 24 (2022) · low 8 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FMF

114in 2025

2007high 239 (2026) · low 74 (2008)2026

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

Recalls per year · FMF

19in 2023

2007high 19 (2023) · low 0 (2016)2026

Class I (19 since 2007) Class II/III not classified

Adverse event reports per year · FMF

4,181in 2025

2007high 5,874 (2021) · low 186 (2011)2025

MAUDE reports naming product code FMF, 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	23	90	6	674
2008	9	74	11	691
2009	14	94	15	913
2010	11	130	12	679
2011	16	109	3	186
2012	9	86	6	307
2013	12	154	1	326
2014	13	84	1	244
2015	11	87	2	273
2016	12	146	0	684
2017	13	135	3	1,858
2018	8	87	2	3,952
2019	11	146	1	5,863
2020	15	107	2	5,334
2021	20	175	1	5,874
2022	24	211	2	5,233
2023	22	173	19 (18)	5,214
2024	14	130	0	5,122
2025	13	114	0	4,181
2026	9	239	2 (1)	—

What is it indicated for?

For injection of lidocaine subcutaneously or intramuscularly for

infiltration and nerve block.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K992404 · printed Nov 4, 2026

Cite this page

510(k) Report. “K992404: The Wand.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992404

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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