Cleared Traditional

K121106 - TRUFORM READY-TO-WEAR COMPRESSION ARM SLEECE TRUFORM READY-TO-WEAR COMPRESSION GAUNTLET

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

K121106 · Surgical Appliance Industries, Inc. · General Hospital
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K121106

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
Combination Product No
PCCP Authorized No
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.

DWL Device Classification - Class 2, Special Controls

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 Consultant

Underwriters Laboratories, Inc.
NED DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DWL Stocking, Medical Support (to Prevent Pooling Of Blood In Legs)

All 24
Devices cleared under the same product code (DWL) and FDA review panel - the closest regulatory comparables to K121106.
FUTURO (TM) TRAVEL KNEE-HIGHS
K123085 · 3M Company · Dec 2012
DR. SCHOLL'S COMPRESSION SOCKS
K123398 · Renfro Corporation · Dec 2012
ELVAREX/ELVAREX SOFT/ELVAREX SOFT SEAMLESS
K123561 · Bsn Medical, Inc. · Dec 2012
CURAD COMPRESSION HOSIERY
K112769 · Medline Industries, Inc. · Mar 2012
VENOTRAIN CURAFLOW
K111662 · Bauerfeind AG · Oct 2011
ANTI-EMBOLISM STOCKINGS, MODELS 71055-00000-02, 71057-00000-02, 71059-00000-02, 71064-00000-02 & 71065-00000-02
K090921 · Beiersdorf, Inc. · Dec 2009

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.