Cleared Traditional

K831148 - HIGH FILTRATION ISO-MASK (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K831148 · Tecnol New Jersey Wound Care, Inc. · General Hospital
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Jul 1984
Decision
466d
Days
Class 2
Risk

K831148 is an FDA 510(k) clearance for the HIGH FILTRATION ISO-MASK. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Tecnol New Jersey Wound Care, Inc. (Walker, US). The FDA issued a Cleared decision on July 17, 1984 after a review of 466 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Tecnol New Jersey Wound Care, Inc. devices

Submission Details

510(k) Number K831148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1983
Decision Date July 17, 1984
Days to Decision 466 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
338d slower than avg
Panel avg: 128d · This submission: 466d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FXX Mask, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FXX Mask, Surgical

All 606
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