Cleared Traditional

K133080 - Plus Surgical Drapes (EO Sterilized), PMDB-XXX (FDA 510(k) Clearance)

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

K133080 · Foshan Nanhai Plus Medical Co, Ltd. · General Hospital
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Jun 2015
Decision
632d
Days
Class 2
Risk

K133080 is an FDA 510(k) clearance for the Plus Surgical Drapes (EO Sterilized), PMDB-XXX. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Foshan Nanhai Plus Medical Co, Ltd. (Dover, US). The FDA issued a Cleared decision on June 24, 2015 after a review of 632 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - 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 Foshan Nanhai Plus Medical Co, Ltd. devices

Submission Details

510(k) Number K133080 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2013
Decision Date June 24, 2015
Days to Decision 632 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
504d slower than avg
Panel avg: 128d · This submission: 632d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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.