Sway System (Sports Plus) (K262000): 510(k) cleared for Sway Medical, Inc.
Sway System (Sports Plus) (K262000): 510(k) cleared for Sway Medical, Inc. (Oklahoma): 510(k) cleared for Sway Medical, Inc. Its amount of 125 is below the median of 138 (47th percentile). Dated 17 days ago, it is in the active follow-up window. Score 36/100. 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: 125 · 47th percentile of 414 FDAPulse records · 0.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 2 related OK FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262000 |
| Device | Sway System (Sports Plus) |
| Applicant | Sway Medical, Inc. |
| Specialty / panel | Neurology |
| Product code | POM |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-15 |
| Decision date | 2026-10-18 |
| Review time (days) | 125 |
| Third-party review | No |
| Applicant location | Tulsa, OK, US |
| amount percentile | 47th of 414 (median 138, 0.9x median) |
| Peer records CSV (3 OK records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 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: 2026-10-18
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (OK first): Everslide (K260117) · PDR Airway Device (K262937) · SmartIPL_NI System (K241973) · Multiple therapy aesthetic treatment device (BHS 202 UNYQUE) · TECAR Therapy Device (TC2000, TC2001) (K252288) · 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: Sway System (Sports Plus) (K262000): 510(k) cleared for Sway Medical, Inc. and 3 Oklahoma peers
- Oklahoma FDAPulse records like this one: 3
- Sway System (Sports Plus) (K262000): 510(k) cleared for Sway Medical, Inc.'s amount: 47th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Oklahoma peer: $600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 125-day review: this device is a strong predicate for similar products.
- Posted 17 days ago.
What is the FDAPulse record for Sway System (Sports Plus) (K262000): 510(k) cleared for Sway Medical, Inc. in Oklahoma?
Sway System (Sports Plus) (K262000) by Sway Medical, Inc. was cleared on 2026-10-18 after 125 days of review.
How does Sway System (Sports Plus) (K262000): 510(k) cleared for Sway Medical, Inc. compare to other Oklahoma FDAPulse records?
Its amount of 125 is below the median (47th percentile); smaller records often move faster and face less competition. It is 17 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
Sway System (Sports Plus) (K262000) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Sway System (Sports Plus) (K262000) | OK | 2026-10-18 |
| 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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