# K223406: SmartRelease Endoscopic Soft Tissue Release System

- Pathway: 510(k) (Traditional)
- Applicant: Microaire Surgical Instruments
- Decided: Feb 2, 2023 after 85 days
- Product code: HRX (Arthroscope)
- Device class: 2
- Regulation: 21 CFR 888.1100
- Recalls of this device: 1 (0 Class I)
- 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.
2 later devices descend from it; 2 cite it directly.
0 of 29 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
- K252594: UltraGuideCTR® image guided soft tissue release system (2025), 0 descendants of its own
- K242417: VECTR – Video Endoscopic Carpal Tunnel Release System (2024), 0 descendants of its own

## Recalls of this device
- May 7, 2025 · Class II · Z-1975-2025: Potential that the blade can unintentionally cut tissue prior to the user deploying the blade.

## Indications for use
The MicroAire® SmartRelease® Endoscopic Soft Tissue Release System is indicated for: • Carpal tunnel release in the wrist • Cubital tunnel release in the elbow • Trigger finger release in the hand

Source page: https://510kreport.com/device/K223406
Methodology: https://510kreport.com/methodology