Cleared Traditional

K892892 - NET STRETCHER PAD (TM)

K892892 is an FDA 510(k) clearance for NET STRETCHER PAD (TM), manufactured by North East Technology. The device is a Class 1 General Hospital device with product code FPP cleared through the Traditional 510(k) pathway after a 215-day FDA review.

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

FDA 510(k) Submission Details - K892892

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.

FPP Device Classification - Class 1, General Controls

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.