Cleared Traditional

VACUUM WAND AND UNI-READER (K821644) - FDA 510(k) Clearance

Class I Physical Medicine device.

K821644 · Fred Sammons, Inc. · Physical Medicine device
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Jun 1982
Decision
8d
Days
Class 1
Risk

K821644 is an FDA 510(k) clearance for the VACUUM WAND AND UNI-READER. Classified as System, Communication, Non-powered (product code ILP), Class I - General Controls.

Submitted by Fred Sammons, Inc. (Burr Ridge, US). The FDA issued a Cleared decision on June 11, 1982 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3700 - 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 Fred Sammons, Inc. devices

Submission Details

510(k) Number K821644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1982
Decision Date June 11, 1982
Days to Decision 8 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
107d faster than avg
Panel avg: 115d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ILP System, Communication, Non-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3700
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 - ILP System, Communication, Non-powered

All 17
Devices cleared under the same product code (ILP) and FDA review panel - the closest regulatory comparables to K821644.
TELEPHONE ADAPTOR-PERSONS CANT ANSWER
K823615 · Fred Sammons, Inc. · Dec 1982
PLASTIC SLIP-ON PEN/PENCIL HOLDER
K823616 · Fred Sammons, Inc. · Dec 1982
PLASTIC SLIP-ON POINTS W/RUBBER TIP FOR
K823617 · Fred Sammons, Inc. · Dec 1982
STIM STAND
K811483 · Fred Sammons, Inc. · Jun 1981
BOOK HOLDER
K811487 · Fred Sammons, Inc. · Jun 1981
NON-POWERED COMMUNICATION SYSTEMS
K810452 · Fred Sammons, Inc. · Mar 1981