Cleared Traditional

K923283 - SUP 5415 SINGLE USE ONLY STERILE HOSPITAL KIT

K923283 is an FDA 510(k) clearance for SUP 5415 SINGLE USE ONLY STERILE HOSPIT..., manufactured by Savoy Medical Supply Co., Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K923283 · Savoy Medical Supply Co., Inc. · General Hospital
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Jan 1993
Decision
182d
Days
Class 2
Risk

K923283 is an FDA 510(k) clearance for the SUP 5415 SINGLE USE ONLY STERILE HOSPITAL KIT. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Savoy Medical Supply Co., Inc. (Hauppauge, US). The FDA issued a Cleared decision on January 4, 1993 after a review of 182 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 Savoy Medical Supply Co., Inc. devices

FDA 510(k) Submission Details - K923283

510(k) Number K923283 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received July 06, 1992
Decision Date January 04, 1993
Days to Decision 182 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
53d slower than avg
Panel avg: 129d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKX Device Classification - Class 2, Special Controls

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 288
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K923283.
ARTHROBOT BI-FOLD DRAPE
K932253 · Andronic Devices, Ltd. · Feb 1994
VARIOUS UTILITY/SURGICAL DRAPE, STERILE, DISPOSABL
K920346 · Trinity Laboratories, Inc. · Mar 1993
COMPEL SURGICAL DRAPES
K923811 · Standard Textile Co., Inc. · Feb 1993
DRAPE UTILITY/SURGICAL STERILE DISPOSABLE
K920284 · Trinity Laboratories, Inc. · Oct 1992
ULCER WOUND TRAY
K922828 · Ulti-Med Intl., Inc. · Sep 1992
E.R. SUTURE TRAY, STERILE, DISPOSABLE
K920518 · Trinity Laboratories, Inc. · Aug 1992