Cleared Traditional

PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS (K080629) - FDA 510(k) Clearance

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

K080629 · Promedical Products Co., Ltd. · General Hospital
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Oct 2008
Decision
229d
Days
Class 2
Risk

K080629 is an FDA 510(k) clearance for the PROMEDICAL SURGICAL DRAPES, PROMEDICAL SURGICAL MAYO STAND COVER, BAND BAGS. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Promedical Products Co., Ltd. (Changzhou, Jiangsu, CN). The FDA issued a Cleared decision on October 20, 2008 after a review of 229 days - an extended review cycle.

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: 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 Promedical Products Co., Ltd. devices

Submission Details

510(k) Number K080629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2008
Decision Date October 20, 2008
Days to Decision 229 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
100d slower than avg
Panel avg: 129d · This submission: 229d
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.

Regulatory Peers - KKX Drape, Surgical

All 449
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K080629.
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ControlRad Sterile Cover
K200238 · Controlrad, Inc. · Apr 2020
STERI-DRAPE SURGICAL DRAPES
K031287 · 3M Company · Sep 2003
CONVERTORS ISO BAC DRAPE MATERIAL
K931267 · Baxter Healthcare Corp · Nov 1994