Cleared Traditional

K121106 - TRUFORM READY-TO-WEAR COMPRESSION ARM S...

K121106 is the FDA 510(k) clearance for TRUFORM READY-TO-WEAR COMPRESSION ARM S... by Surgical Appliance Industries, Inc.. It is a Class 2 General Hospital device (product code DWL) cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K121106 · Surgical Appliance Industries, Inc. · General Hospital
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Optimized for regulatory review, auditing and printing
Apr 2012
Decision
15d
Days
Class 2
Risk

K121106 is an FDA 510(k) clearance for the TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSIO.... Classified as Stocking, Medical Support (to Prevent Pooling Of Blood In Legs) (product code DWL), Class II - Special Controls.

Submitted by Surgical Appliance Industries, Inc. (Cincinnati, US). The FDA issued a Cleared decision on April 27, 2012 after a review of 15 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5780 - 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 Surgical Appliance Industries, Inc. devices

Submission Details

510(k) Number K121106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2012
Decision Date April 27, 2012
Days to Decision 15 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 129d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code DWL Stocking, Medical Support (to Prevent Pooling Of Blood In Legs)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5780
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 - DWL Stocking, Medical Support (to Prevent Pooling Of Blood In Legs)

All 9
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