510(k) · Cleared
ClearedIASIS i2 Relaxation Neurofeedback System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleared on Mar 13, 2026 as substantially equivalent to K945826 (Medical Device Inspection Co., Inc., 1995) and 1 other predicate after a 179-day review. Its family tree reaches back 3 generations to 1995.
- Decided
- Mar 13, 2026
- Review
- 179 days
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K920038 (1995). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK920038 Neurosearch-4Lexicor · 1995
- 2 generations backK961645 MRS-2DLexicor Medical Technology, Inc. · 1996
- 1 generation backK990538 Brainmaster 2E Module and Software Biofeedback DeviceBrainmaster · 1999
- This deviceK252923 IASIS i2 Relaxation Neurofeedback SystemIasis Technologies · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K920038 | Neurosearch-4 | Lexicor | 1995 | — |
| −2 | K961645 | MRS-2D | Lexicor Medical Technology, Inc. | 1996 | — |
| −1 | K990538 | Brainmaster 2E Module and Software Biofeedback Device | Brainmaster | 1999 | — |
| 0 (this device) | K252923 | IASIS i2 Relaxation Neurofeedback System | Iasis Technologies | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 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 this category? 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? (2)
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 |
|---|---|---|---|
| * | K945826 | J & J I-330 Series Physiological Monitoring & Biofeedback Instument and Use Software…Summary page 6…SEN, HCC Review Panel: Neurology 6. Legally Marketed Predicate Devices a. Primary Predicate Device: 510(K) Number: K945826 Trade/Device Name: J&J I‐330 SERIES PHYSIOLOGICAL MONITORING & BIOFEEDBACK INSTUMENT AND USE… | 1995 |
| * | K990538 | Brainmaster 2E Module and Software Biofeedback DeviceSummary page 6…s II Product Code: HCC Review Panel: Neurology b. Secondary Predicate Device: 510(K) Number: K990538 Trade/Device Name: The BrainMaster 2E MODULE AND SOFTWARE BIOFEEDBACK DEVICE Regu… | 1999 |
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 31 years and passes through 4 companies; a new generation was cleared every 2.5 years on median.
- None of the 5 ancestors has a recall.
- 1 other device also cites its predicate K945826.
What is it indicated for?
IASIS i2 Relaxation Neurofeedback System is a neurofeedback device intended for relaxation and stress reduction through the use of EEG biofeedback.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252923 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252923: IASIS i2 Relaxation Neurofeedback System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252923
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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