Cleared Traditional

MOTIONSPECT (K895881) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K895881 · Baltimore Therapeutic Equipment Co. · Gastroenterology & Urology device
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Apr 1990
Decision
187d
Days
Class 3
Risk

K895881 is an FDA 510(k) clearance for the MOTIONSPECT. Classified as Column, Adsorption, Low Density, Lipoprotein (product code LXW), Class III - Premarket Approval.

Submitted by Baltimore Therapeutic Equipment Co. (Hanover, US). The FDA issued a Cleared decision on April 10, 1990 after a review of 187 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. High regulatory complexity profile. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Baltimore Therapeutic Equipment Co. devices

Submission Details

510(k) Number K895881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1989
Decision Date April 10, 1990
Days to Decision 187 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 130d · This submission: 187d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LXW Column, Adsorption, Low Density, Lipoprotein
Device Class Class 3 - Premarket Approval
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.