Cleared Traditional

K133858 - TENSYN BAND

K133858 is an FDA 510(k) clearance for TENSYN BAND, manufactured by Dallen Medical, Inc.. The device is a Class 2 Orthopedic device with product code HTN cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K133858 · Dallen Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
71d
Days
Class 2
Risk

K133858 is an FDA 510(k) clearance for the TENSYN BAND. Classified as Washer, Bolt Nut (product code HTN), Class II - Special Controls.

Submitted by Dallen Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on February 28, 2014 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory 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 Dallen Medical, Inc. devices

FDA 510(k) Submission Details - K133858

510(k) Number K133858 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2013
Decision Date February 28, 2014
Days to Decision 71 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 122d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HTN Device Classification - Class 2, Special Controls

Product Code HTN Washer, Bolt Nut
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 Orthopedic devices follow this clearance model.

Regulatory Peers - HTN Washer, Bolt Nut

All 70
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