Cleared Traditional

K801701 - BAUER & BLACK RIGID WRIST BRACE

K801701 is the FDA 510(k) clearance for BAUER & BLACK RIGID WRIST BRACE by Bd Becton Dickinson Vacutainer Systems Preanalytic. It is a Class 1 Physical Medicine device (product code IQI) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K801701 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Physical Medicine device
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Aug 1980
Decision
14d
Days
Class 1
Risk

K801701 is an FDA 510(k) clearance for the BAUER & BLACK RIGID WRIST BRACE. Classified as Orthosis, Limb Brace (product code IQI), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on August 7, 1980 after a review of 14 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 Bd Becton Dickinson Vacutainer Systems Preanalytic devices

Submission Details

510(k) Number K801701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1980
Decision Date August 07, 1980
Days to Decision 14 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: 115d · This submission: 14d
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 18
Devices cleared under the same product code (IQI) and FDA review panel - the closest regulatory comparables to K801701.
FOREARM & KNEE STRAPS
K811490 · Fred Sammons, Inc. · Jun 1981
LIMB ORTHOSIS
K810443 · Fred Sammons, Inc. · Mar 1981
C-SPLINT
K802104 · Cutter Laboratories, Inc. · Sep 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