# K181819: SMARTRELEASE Endoscopic Soft Tissue Release System

- Pathway: 510(k) (Traditional)
- Applicant: Microaire Surgical Instruments, LLC
- Decided: Nov 6, 2018 after 120 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: 5 generations back to K844002 (1984). 25 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080133: Mountable Endoscopic Blade, A.M. Surgical, Inc. (2008) Summary page 4.
- K080560: Henke Sass Wolf of America Arthroscope, Henke Sass Wolf of America, Inc. (2008) Summary page 5.
- K032119: Paragon Medical Surgical Instrument Delivery System Various, Paragon Medical, Inc. (2003) Summary page 5.
- (no number) A.M. Surgical STRATOS® Endoscopic Release System – Carpal and Cubital Tunnel Release: named in the summary without a submission number

## Most influential descendants
- K223406: SmartRelease Endoscopic Soft Tissue Release System (2023), 2 descendants of its own
- K222490: HBL Blade Assembly (2022), 1 descendant of its own
- K252020: TunnelVision Endoscopic Soft Tissue Release System and the HBL Blade Assembly (2025), 0 descendants of its own
- 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

## Indications for use
The MicroAire SMARTRELEASE® 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

Source page: https://510kreport.com/device/K181819
Methodology: https://510kreport.com/methodology