# K222490: HBL Blade Assembly

- Pathway: 510(k) (Traditional)
- Applicant: Hand Biomechanics Lab, Inc.
- Decided: Nov 14, 2022 after 89 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: 6 generations back to K844002 (1984). 26 ancestors in all.
1 later device descends from it; 1 cites it directly.
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 4.

## Most influential descendants
- K252020: TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K222490
Methodology: https://510kreport.com/methodology