Sleep Analysis Module (K261521): 510(k) cleared for Neurotronics, LLC
Sleep Analysis Module (K261521): 510(k) cleared for Neurotronics, LLC (Florida): 510(k) cleared for Neurotronics, LLC. Its amount of 155 is above the median of 138 (58th percentile). Dated 27 days ago, it is in the active follow-up window. Score 48/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 155 · 58th percentile of 414 FDAPulse records · 1.1x the median
Free preview: all 14 published fields of this record are shown below. Locked: 15 related FL FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261521 |
| Device | Sleep Analysis Module |
| Applicant | Neurotronics, LLC |
| Specialty / panel | Neurology |
| Product code | OLZ |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-05-07 |
| Decision date | 2026-10-09 |
| Review time (days) | 155 |
| Third-party review | No |
| Applicant location | Alachua, FL, US |
| amount percentile | 58th of 414 (median 138, 1.1x median) |
| Peer records CSV (16 FL records) | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-09
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (FL first): Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) · Hemotag Analysis Software (HAS) (K252736) · Durashield Device Kit (K252995) · epi-ConneKt Wound Matrix (K260530) · BellaTek Bars (K260940) · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: Sleep Analysis Module (K261521): 510(k) cleared for Neurotronics, LLC and 16 Florida peers
- Florida FDAPulse records like this one: 16
- Sleep Analysis Module (K261521): 510(k) cleared for Neurotronics, LLC's amount: 58th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Florida peer: $3,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
48 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- 155-day review, longer than typical.
- Posted 27 days ago.
What is the FDAPulse record for Sleep Analysis Module (K261521): 510(k) cleared for Neurotronics, LLC in Florida?
Sleep Analysis Module (K261521) by Neurotronics, LLC was cleared on 2026-10-09 after 155 days of review.
How does Sleep Analysis Module (K261521): 510(k) cleared for Neurotronics, LLC compare to other Florida FDAPulse records?
Its amount of 155 sits in the upper half (58th percentile) of 414 records; the median is 138. It is 27 days old, still within a typical 45-day follow-up window.
Sleep Analysis Module (K261521) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Sleep Analysis Module (K261521) | FL | 2026-10-09 |
| 7D Surgical System (10-0001) (K260403) | CA | 2026-10-19 |
| cCeLL - In vivo (K260315) | KR | 2026-10-16 |
| Neurora (K260064) | NH | 2026-10-02 |
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