Cleared Traditional

K801788 - HUMEROUS FRACTURE BRACE

K801788 is the FDA 510(k) clearance for HUMEROUS FRACTURE BRACE by Hosmer Dorrance Corp.. It is a Class 1 Physical Medicine device (product code IQI) cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K801788 · Hosmer Dorrance Corp. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1980
Decision
9d
Days
Class 1
Risk

K801788 is an FDA 510(k) clearance for the HUMEROUS FRACTURE BRACE, ULNA FRACTURE. Classified as Orthosis, Limb Brace (product code IQI), Class I - General Controls.

Submitted by Hosmer Dorrance Corp. (Mchenry, US). The FDA issued a Cleared decision on August 7, 1980 after a review of 9 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.

View all Hosmer Dorrance Corp. devices

Submission Details

510(k) Number K801788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 1980
Decision Date August 07, 1980
Days to Decision 9 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 115d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 19
Devices cleared under the same product code (IQI) and FDA review panel - the closest regulatory comparables to K801788.
C-SPLINT
K802104 · Cutter Laboratories, Inc. · Sep 1980
BAUER & BLACK RIGID WRIST BRACE
K801701 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1980
BK-1520-01 ECONOMY WRIST SUPPORT, CHILD
K801708 · Fred Sammons, Inc. · Aug 1980
SECUTE ELBOW BAND
K791248 · Conphar, Inc. · Jul 1979
SECUTEX WRIST BRACE
K791249 · Conphar, Inc. · Jul 1979
SECUTEX KNEE BAND
K791266 · Conphar, Inc. · Jul 1979