510(k) · Cleared
ClearedNess Children System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ness-Neuromuscular Electrical Stimulation Systems · IPG Shoe, Cast
Cleared on Feb 5, 2003 as substantially equivalent to K022776 (Ness-Neuromuscular Electrical Stimulation Systems, 2002) after a 44-day review. Its family tree reaches back 4 generations to 1981.
- Decided
- Feb 5, 2003
- Review
- 44 days
- Class
- Class I
- Product code
- IPG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K813008 (1981). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK813008 Respond II...Neuromuscular StimulatorMedtronic Vascular · 1981
- 3 generations backK952273 Handmaster NMS1Neuromusclar Electrical Stimulation Systems, Ltd. · 1996
- 2 generations backK982482 Handmaster NMS1N.E.S.S. Nuromuscular Electrical Stimulation Syst · 1998
- 1 generation backK022776 Ness SystemNess-Neuromuscular Electrical Stimulation Systems · 2002
- This deviceK024279 Ness Children SystemNess-Neuromuscular Electrical Stimulation Systems · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K813008 | Respond II...Neuromuscular Stimulator | Medtronic Vascular | 1981 | — |
| −3 | K952273 | Handmaster NMS1 | Neuromusclar Electrical Stimulation Systems, Ltd. | 1996 | — |
| −2 | K982482 | Handmaster NMS1 | N.E.S.S. Nuromuscular Electrical Stimulation Syst | 1998 | — |
| −1 | K022776 | Ness System | Ness-Neuromuscular Electrical Stimulation Systems | 2002 | — |
| 0 (this device) | K024279 | Ness Children System | Ness-Neuromuscular Electrical Stimulation Systems | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
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 IPG? 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
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 | Decided |
|---|---|---|---|
| * | K022776 | Ness System | 2002 |
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 22 years and passes through 4 companies; a new generation was cleared every 3.9 years on median.
- None of the 6 ancestors has a recall.
- 1 other device also cites its predicate K022776.
How does its category compare?
All IPG devicesIPG Shoe, Cast: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IPG
FDA has decided no IPG device since 2007.
Median 510(k) review, days · IPG
Too few IPG 510(k)s in any year since 2007 to give a median.
Recalls per year · IPG
No recall names IPG since 2007.
Adverse event reports per year · IPG
1in 2024
MAUDE reports naming product code IPG, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The NESS Children System is intended for pediatric use for the following indications: maintenance or increase of range of motion, reduction of muscle spasm, prevention or retardation of disuse atrophy, muscle reeducation, and increasing local blood circulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K024279 · printed Nov 6, 2026
Cite this page
510(k) Report. “K024279: Ness Children System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K024279
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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