Cleared Traditional

K211297 - SMARTRELEASE Endoscopic Soft Tissue Release System (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211297 · Microaire Surgical Instruments · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2021
Decision
57d
Days
Class 2
Risk

K211297 is an FDA 510(k) clearance for the SMARTRELEASE Endoscopic Soft Tissue Release System. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by Microaire Surgical Instruments (Charlottesville, US). The FDA issued a Cleared decision on June 24, 2021 after a review of 57 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 888.1100 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Microaire Surgical Instruments devices

Submission Details

510(k) Number K211297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2021
Decision Date June 24, 2021
Days to Decision 57 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 128d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 679
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K211297.
Freedom DS™ Decompression System
K253523 · Spinal Simplicity · Apr 2026
VantageTM Lumbar Decompression Kit
K252546 · Allevion Medical, LLC · Mar 2026
MiiS Horus Arthroscope (EJA 100)
K253217 · Medimaging Integrated Solution, Inc (Miis) · Dec 2025
PUREVUE™ FMS
K250795 · W.O.M. World of Medicine GmbH · Dec 2025
Articulator Arthroscopic Bur
K252666 · Joint Preservation Innovations, LLC · Nov 2025
Kyphoplasty Balloon Dilatation Catheters
K252458 · Shanghai Lange Medtech Co., Ltd. · Nov 2025