510(k) · Cleared

Cleared

Diamond Medistim

K041390510(k) TraditionalCleared Feb 9, 2005260-day reviewClass II21 CFR 890.5850

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

Diamond Systems USA, Inc. · IPF Stimulator, Muscle, Powered

Cleared on Feb 9, 2005 as substantially equivalent to K926410 (Bowater Research, Inc., 1993) after a 260-day review. Its family tree reaches back 1 generation to 1993.

Decided: Feb 9, 2005
Review: 260 days
Class: Class II
Product code: IPF
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K926410 (1993). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK926410 Ultratone 8+ & 20Bowater Research, Inc. · 1993
This deviceK041390 Diamond MedistimDiamond Systems USA, Inc. · 2005

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K926410	Ultratone 8+ & 20	Bowater Research, Inc.	1993	—
0 (this device)	K041390	Diamond Medistim	Diamond Systems USA, Inc.	2005	—

FIG. 1 — Lineage of K041390, 1993–2005Source: 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 IPF? 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 IPF device

#1 K241433 EVE Synergy (EVE-20M)score 19.7 · 25 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
*	K926410	Ultratone 8+ & 20 Summary page 2 …Stimulator 32 Predicate Device: Ultratone 20 (K926410) Description of Device: The Diamond MediStim is a powered muscle stimulator, which is an electrica…	Bowater Research, Inc.	1993	—

Also cleared against K926410: 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?

Its one ancestor has no recall.
1 other device also cites its predicate K926410.

How does its category compare?

All IPF devices

IPF Stimulator, Muscle, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IPF

3in 2025

2007high 15 (2021) · low 3 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IPF

257in 2025

2007high 275 (2011) · low 43 (2015)2026

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

Recalls per year · IPF

1in 2023

2007high 3 (2012) · low 0 (2007)2026

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

Adverse event reports per year · IPF

8in 2025

2007high 213 (2008) · low 2 (2017)2025

MAUDE reports naming product code IPF, 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	8	143	0	11
2008	6	140	1	213
2009	7	216	0	150
2010	4	121	0	14
2011	4	275	1	25
2012	4	269	3	16
2013	10	180	0	6
2014	4	264	0	19
2015	3	43	0	11
2016	7	113	0	8
2017	5	110	0	2
2018	5	73	0	3
2019	4	133	0	10
2020	9	121	0	13
2021	15	98	0	3
2022	7	108	0	4
2023	9	255	1	8
2024	7	201	0	5
2025	3	257	0	8
2026	3	206	0	—

What is it indicated for?

1. Relaxation of muscle spasms;

2. Prevention or retardation of disuse atrophy;

3. Increasing local blood circulation;

4. Muscle re-education;

5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis; and

6. Maintaining or increasing range of molion.

When the device is used in a manner that delivers continuous, uninterrupted pulses, it is indicated only for the relaxation of muscle spasms. The Variable Stim output mode delivers continuous, uninterrupted pulses. The Auto Stim output mode delivers bursts of pulses that are interrupted with I second "off" periods.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041390 · printed Nov 5, 2026

Cite this page

510(k) Report. “K041390: Diamond Medistim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041390

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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