Cleared Traditional

NET STRETCHER PAD (TM) (K892892) - FDA 510(k) Clearance

Class I General Hospital device.

K892892 · North East Technology · General Hospital
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Nov 1989
Decision
215d
Days
Class 1
Risk

K892892 is an FDA 510(k) clearance for the NET STRETCHER PAD (TM). Classified as Stretcher, Hand-carried (product code FPP), Class I - General Controls.

Submitted by North East Technology (Geneva On The Lake, US). The FDA issued a Cleared decision on November 21, 1989 after a review of 215 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6900 - the FDA general hospital 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all North East Technology devices

Submission Details

510(k) Number K892892 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 1989
Decision Date November 21, 1989
Days to Decision 215 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 129d · This submission: 215d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FPP Stretcher, Hand-carried
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6900
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.