Cleared Traditional

K843309 - UNIFLEX DANNINGER

K843309 is the FDA 510(k) clearance for UNIFLEX DANNINGER by Buckman Co., Inc.. It is a Class 1 Physical Medicine device (product code BXB) cleared through the Traditional 510(k) pathway after a 54-day FDA review.

K843309 · Buckman Co., Inc. · Physical Medicine device
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Oct 1984
Decision
54d
Days
Class 1
Risk

K843309 is an FDA 510(k) clearance for the UNIFLEX DANNINGER. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Buckman Co., Inc. (Martinez, US). The FDA issued a Cleared decision on October 16, 1984 after a review of 54 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5380 - 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 Buckman Co., Inc. devices

Submission Details

510(k) Number K843309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1984
Decision Date October 16, 1984
Days to Decision 54 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
61d faster than avg
Panel avg: 115d · This submission: 54d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code BXB Exerciser, Powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.5380
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 - BXB Exerciser, Powered

All 32
Devices cleared under the same product code (BXB) and FDA review panel - the closest regulatory comparables to K843309.
EMPI MODEL 100, CPM(POWER EXCERISE EQUIPMENT)
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K843493 · Richards Medical Co., Inc. · Sep 1984
CONTINUOUS PASSIVE MOTION
K841674 · Chattanooga Group, Inc. · May 1984
STRYKER LEG EXERCISER
K831910 · Stryker Corp. · Jul 1983