Cleared Traditional

K803212 - BAUER & BLACK ARM SLING W/DETACH. POUCH

K803212 is an FDA 510(k) clearance for BAUER & BLACK ARM SLING W/DETACH. POUCH, manufactured by Bd Becton Dickinson Vacutainer Systems Preanalytic. The device is a Class 1 Physical Medicine device with product code ILI cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K803212 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Physical Medicine device
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Jan 1981
Decision
22d
Days
Class 1
Risk

K803212 is an FDA 510(k) clearance for the BAUER & BLACK ARM SLING W/DETACH. POUCH. Classified as Sling, Arm (product code ILI), Class I - General Controls.

Submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Washington, US). The FDA issued a Cleared decision on January 8, 1981 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3640 - 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

FDA 510(k) Submission Details - K803212

510(k) Number K803212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1980
Decision Date January 08, 1981
Days to Decision 22 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
93d faster than avg
Panel avg: 115d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

ILI Device Classification - Class 1, General Controls

Product Code ILI Sling, Arm
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3640
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 - ILI Sling, Arm

All 15
Devices cleared under the same product code (ILI) and FDA review panel - the closest regulatory comparables to K803212.
LIMB HOLDER ARM SLING
K812480 · Maddak, Inc. · Sep 1981
ARM SLINGS
K812345 · Fred Sammons, Inc. · Sep 1981
CONPHAR ARM SLINGS
K803139 · Conphar, Inc. · Jan 1981
TRIANGULAR BANDAGE CAT.#191
K802006 · Pollak (Intl.), Ltd. · Sep 1980
BK-6157-02 C.V.A SLING, MEDIUM&LARGE
K801713 · Fred Sammons, Inc. · Aug 1980
ECONOMY IMMOBILIZATION AND VELPEAN SLING
K760574 · Richard'S Medical Equip., Inc. · Oct 1976