Cleared Traditional

ENVIROTENT (BED) (K881725) - FDA 510(k) Clearance

Class I General Hospital device.

K881725 · Envirotents, Inc. · General Hospital
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Nov 1988
Decision
200d
Days
Class 1
Risk

K881725 is an FDA 510(k) clearance for the ENVIROTENT (BED). Classified as Bed, Manual (product code FNJ), Class I - General Controls.

Submitted by Envirotents, Inc. (Denver, US). The FDA issued a Cleared decision on November 8, 1988 after a review of 200 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5120 - 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 Envirotents, Inc. devices

Submission Details

510(k) Number K881725 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1988
Decision Date November 08, 1988
Days to Decision 200 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
71d slower than avg
Panel avg: 129d · This submission: 200d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FNJ Bed, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5120
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.