Cleared Traditional

K760307 - BEDPAN, SINGLE PATIENT USE, TECNOL (FDA 510(k) Clearance)

Class I General Hospital device.

K760307 · Tecnol New Jersey Wound Care, Inc. · General Hospital
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Aug 1976
Decision
16d
Days
Class 1
Risk

K760307 is an FDA 510(k) clearance for the BEDPAN, SINGLE PATIENT USE, TECNOL. Classified as Bedpan (product code FOB), Class I - General Controls.

Submitted by Tecnol New Jersey Wound Care, Inc. (Hammonton, US). The FDA issued a Cleared decision on August 11, 1976 after a review of 16 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6730 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Tecnol New Jersey Wound Care, Inc. devices

Submission Details

510(k) Number K760307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 1976
Decision Date August 11, 1976
Days to Decision 16 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
112d faster than avg
Panel avg: 128d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FOB Bedpan
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6730
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.