# K252020: TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly

- Pathway: 510(k) (Traditional)
- Applicant: Hand Biomechanics Lab, Inc.
- Decided: Oct 15, 2025 after 107 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K844002 (1984). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181819: SMARTRELEASE Endoscopic Soft Tissue Release System, Microaire Surgical Instruments, LLC (2018) Summary page 5.
- K222490: HBL Blade Assembly, Hand Biomechanics Lab, Inc. (2022) Summary page 5.

## Indications for use
The TunnelVision Endoscopic Soft Tissue Release System is indicated for use in minimally invasive ligament or fascia release: Carpal tunnel release in the wrist Cubital tunnel release in the elbow The HBL Blade Assembly is indicated for use with the TunnelVision Endoscopic Soft Tissue Release System, the 3M Agee Inside Job Carpal Tunnel Release System, or the MicroAire SmartRelease Endoscopic Soft Tissue Release System in minimally invasive ligament or fascia release: Carpal tunnel release in the wrist Cubital tunnel release in the elbow

Source page: https://510kreport.com/device/K252020
Methodology: https://510kreport.com/methodology