Cleared Traditional

K811704 - MULTITUBULAR AIR SPLINT KIT

K811704 is an FDA 510(k) clearance for MULTITUBULAR AIR SPLINT KIT, manufactured by Roger Cestac & Assoc.. The device is a Class 1 Physical Medicine device with product code IQI cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K811704 · Roger Cestac & Assoc. · Physical Medicine device
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Jul 1981
Decision
15d
Days
Class 1
Risk

K811704 is an FDA 510(k) clearance for the MULTITUBULAR AIR SPLINT KIT. Classified as Orthosis, Limb Brace (product code IQI), Class I - General Controls.

Submitted by Roger Cestac & Assoc. (Mchenry, US). The FDA issued a Cleared decision on July 1, 1981 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3475 - the FDA physical medicine 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.

FDA 510(k) Submission Details - K811704

510(k) Number K811704 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1981
Decision Date July 01, 1981
Days to Decision 15 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 116d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

IQI Device Classification - Class 1, General Controls

Product Code IQI Orthosis, Limb Brace
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3475
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IQI Orthosis, Limb Brace

All 39
Devices cleared under the same product code (IQI) and FDA review panel - the closest regulatory comparables to K811704.
OBTHOSES
K821641 · Fred Sammons, Inc. · Jun 1982
WARM'N FORM SPORTS SUPPORTS
K821582 · Jerome Medical · Jun 1982
WARM & FORM KNEE SUPPORTS
K820469 · Thermo-Mold Medical Products, Inc. · Mar 1982
ANKLE-FOOT CAST/SPLINT
K811690 · Surgical Appliance Industries, Inc. · Jun 1981
ORTHO-FRAC KIT
K811456 · Orthomedics · Jun 1981
FOREARM & KNEE STRAPS
K811490 · Fred Sammons, Inc. · Jun 1981
K811704 · MULTITUBULAR AIR SPLINT KIT
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