Cleared Traditional

K954556 - SURGICAL CAP

K954556 is an FDA 510(k) clearance for SURGICAL CAP, manufactured by Thai Disposable Products Co., Ltd.. The device is a Class 1 General & Plastic Surgery device with product code FYF cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K954556 · Thai Disposable Products Co., Ltd. · General & Plastic Surgery device
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Mar 1996
Decision
162d
Days
Class 1
Risk

K954556 is an FDA 510(k) clearance for the SURGICAL CAP. Classified as Cap, Surgical (product code FYF), Class I - General Controls.

Submitted by Thai Disposable Products Co., Ltd. (Samutprakaran, TH). The FDA issued a Cleared decision on March 12, 1996 after a review of 162 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4040 - the FDA general and plastic surgery 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Thai Disposable Products Co., Ltd. devices

FDA 510(k) Submission Details - K954556

510(k) Number K954556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1995
Decision Date March 12, 1996
Days to Decision 162 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d slower than avg
Panel avg: 115d · This submission: 162d
Pathway characteristics
Predicate-based equivalence.

FYF Device Classification - Class 1, General Controls

Product Code FYF Cap, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4040
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.

Regulatory Peers - FYF Cap, Surgical

All 18
Devices cleared under the same product code (FYF) and FDA review panel - the closest regulatory comparables to K954556.
SHOE COVER
K972227 · American Seal Co. · Sep 1997
NIOMED SURGICAL CAPS
K955833 · Amerasia Corp. · Mar 1996
NIOMED SURGICAL HOOD
K954454 · Amerasia Corp. · Jan 1996
NIOMED BOUFFANT CAPS
K954455 · Amerasia Corp. · Jan 1996
BOUFFANT CAP
K953878 · American Threshold Industries, Inc. · Jan 1996
SURGEON'S CAP
K953879 · American Threshold Industries, Inc. · Jan 1996