AerFrame Alignment Laser Box (LBV2) (K261865): 510(k) cleared for Stabilix, LLC
AerFrame Alignment Laser Box (LBV2) (K261865): 510(k) cleared for Stabilix, LLC (Texas): 510(k) cleared for Stabilix, LLC. Its amount of 104 is below the median of 138 (37th percentile). Dated 49 days ago, it serves as a historical benchmark. Score 30/100. 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: 104 · 37th percentile of 414 FDAPulse records · 0.8x the median
Free preview: all 14 published fields of this record are shown below. Locked: 11 related TX FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261865 |
| Device | AerFrame Alignment Laser Box (LBV2) |
| Applicant | Stabilix, LLC |
| Specialty / panel | Radiology |
| Product code | IYE |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-04 |
| Decision date | 2026-09-16 |
| Review time (days) | 104 |
| Third-party review | No |
| Applicant location | Dallas, TX, US |
| amount percentile | 37th of 414 (median 138, 0.8x median) |
| Peer records CSV (12 TX 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: 2026-09-16
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (TX first): MyoVista wavECG (DG-200-B15-003) (K260005) · Small Diameter Core Wire (CMAN-000-00); Small Diameter Core · Kinetic Software Library (K260640) · SmartRead(TM) Medical Device Identifier (4100) (DEN260007) · DASH Flu A/B Test (K261347) · 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: AerFrame Alignment Laser Box (LBV2) (K261865): 510(k) cleared for Stabilix, LLC and 12 Texas peers
- Texas FDAPulse records like this one: 12
- AerFrame Alignment Laser Box (LBV2) (K261865): 510(k) cleared for Stabilix, LLC's amount: 37th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Texas peer: $2,400 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
30 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 104-day review: this device is a strong predicate for similar products.
What is the FDAPulse record for AerFrame Alignment Laser Box (LBV2) (K261865): 510(k) cleared for Stabilix, LLC in Texas?
AerFrame Alignment Laser Box (LBV2) (K261865) by Stabilix, LLC was cleared on 2026-09-16 after 104 days of review.
How does AerFrame Alignment Laser Box (LBV2) (K261865): 510(k) cleared for Stabilix, LLC compare to other Texas FDAPulse records?
Its amount of 104 is below the median (37th percentile); smaller records often move faster and face less competition. It is 49 days old; check the official source for later updates before acting. Its Predicate Speed & CAPA Advisory Opportunity Score of 30/100 is modest; treat it as background rather than a priority.
AerFrame Alignment Laser Box (LBV2) (K261865) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| AerFrame Alignment Laser Box (LBV2) (K261865) | TX | 2026-09-16 |
| VenusCT (K260510) | CA | 2026-10-19 |
| AVIEW Aorta Metrics (K260391) | KR | 2026-10-16 |
| Vista AI Scan (K260092) | CA | 2026-10-07 |
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