Cleared Traditional

A.L.A.R.M. (ADJUST. LEG & ANKLE REPOSITIONING MECH (K872525) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K872525 · M.C. Johnson Co., Inc. · Radiology device
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Feb 1988
Decision
242d
Days
Class 2
Risk

K872525 is an FDA 510(k) clearance for the A.L.A.R.M. (ADJUST. LEG & ANKLE REPOSITIONING MECH. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by M.C. Johnson Co., Inc. (Leominster, US). The FDA issued a Cleared decision on February 22, 1988 after a review of 242 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all M.C. Johnson Co., Inc. devices

Submission Details

510(k) Number K872525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 25, 1987
Decision Date February 22, 1988
Days to Decision 242 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
135d slower than avg
Panel avg: 107d · This submission: 242d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - KPR System, X-ray, Stationary

All 117
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K872525.
UNIVERSIX 120
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SOLARIX FV
K953832 · GE Medical Systems · Sep 1995
MTX GENERATOR
K880352 · Philips Medical Systems (Cleveland), Inc. · Jul 1988
SCX INFORMATION MANAGEMENT SYSTEM
K870400 · General Electric Co. · Jun 1987
VRT TABLE W/INTEGRATING TUBE STAND/ELEV
K813173 · General Electric Co. · Dec 1981
DSS 500
K811934 · Philips Medical Systems (Cleveland), Inc. · Aug 1981