Cleared Traditional

TURNERS FOR KNOBS (K823633) - FDA 510(k) Clearance

Class I Physical Medicine device.

K823633 · Fred Sammons, Inc. · Physical Medicine device
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Dec 1982
Decision
22d
Days
Class 1
Risk

K823633 is an FDA 510(k) clearance for the TURNERS FOR KNOBS. Classified as Utensil, Homemaking (product code IKW), Class I - General Controls.

Submitted by Fred Sammons, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 28, 1982 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 890.5050 - 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 K823633 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1982
Decision Date December 28, 1982
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.

Device Classification

Product Code IKW Utensil, Homemaking
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5050
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 - IKW Utensil, Homemaking

All 11
Devices cleared under the same product code (IKW) and FDA review panel - the closest regulatory comparables to K823633.
REACHER & DOOR OPENER
K831545 · Fred Sammons, Inc. · Jun 1983
PORTABLE ELECTRIC CAN OPENER
K823605 · Fred Sammons, Inc. · Dec 1982
CARPET SWEEPER
K823607 · Fred Sammons, Inc. · Dec 1982
TINY FLEX-GLASS, SET OF 4
K821646 · Fred Sammons, Inc. · Jun 1982
JAR HOLDER & OPENER
K813631 · Fred Sammons, Inc. · Jan 1982
HOMEMAKING UTENSILS
K810454 · Fred Sammons, Inc. · Mar 1981