Cleared Traditional

K904735 - DANNIFLEX MODEL 500TM CPM

K904735 is the FDA 510(k) clearance for DANNIFLEX MODEL 500TM CPM by Buckman Co., Inc.. It is a Class 1 Physical Medicine device (product code BXB) cleared through the Traditional 510(k) pathway after a 105-day FDA review.

K904735 · Buckman Co., Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1991
Decision
105d
Days
Class 1
Risk

K904735 is an FDA 510(k) clearance for the DANNIFLEX MODEL 500TM CPM. Classified as Exerciser, Powered (product code BXB), Class I - General Controls.

Submitted by Buckman Co., Inc. (Concord, US). The FDA issued a Cleared decision on January 30, 1991 after a review of 105 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Buckman Co., Inc. devices

Submission Details

510(k) Number K904735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1990
Decision Date January 30, 1991
Days to Decision 105 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
10d faster than avg
Panel avg: 115d · This submission: 105d
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 K904735.
ARTROMOT SB ELBOW ATTACHMENT
K923857 · Buckman Co., Inc. · Feb 1993
DANNINFLEX CPM 800
K923216 · Buckman Co., Inc. · Aug 1992
DANNIFLEX CPM 2000
K923217 · Buckman Co., Inc. · Aug 1992
CLUB FOOT CPM MACHINE
K903851 · Smith & Nephew Richards, Inc. · Oct 1990
ARTROMOT(TM) CPM DEVICES
K895015 · Buckman Co., Inc. · Sep 1989
TOTAL KNEE CPM
K885182 · Invacare Corp. · Mar 1989