Cleared Traditional

K872525 - A.L.A.R.M. (ADJUST. LEG & ANKLE REPOSITIONING MECH

K872525 is an FDA 510(k) clearance for A.L.A.R.M. (ADJUST. LEG & ANKLE REPOSIT..., manufactured by M.C. Johnson Co., Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K872525 · M.C. Johnson Co., Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K872525

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.

KPR Device Classification - Class 2, Special Controls

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 297
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K872525.
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MTX GENERATOR
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BC 1400 HAND POSITIONER
K872316 · Instrumentation Industries, Inc. · Aug 1987
BC 1800 FINGER POSITIONER
K872317 · Instrumentation Industries, Inc. · Aug 1987
SCX INFORMATION MANAGEMENT SYSTEM
K870400 · General Electric Co. · Jun 1987