Cleared Traditional

K921350 - QUALTEX TUBE/CORD ORGANIZER

K921350 is an FDA 510(k) clearance for QUALTEX TUBE/CORD ORGANIZER, manufactured by Deroyal Industries, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K921350 · Deroyal Industries, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1992
Decision
138d
Days
Class 2
Risk

K921350 is an FDA 510(k) clearance for the QUALTEX TUBE/CORD ORGANIZER. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on August 4, 1992 after a review of 138 days - within the typical 510(k) review window.

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 Deroyal Industries, Inc. devices

FDA 510(k) Submission Details - K921350

510(k) Number K921350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1992
Decision Date August 04, 1992
Days to Decision 138 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 129d · This submission: 138d
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 268
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K921350.
INCISSION & DRAINAGE TRAY
K921203 · Trinity Laboratories, Inc. · Aug 1992
DELUXE WOUND CLOSURE TRAY, STERILE, DISPOSABLE
K921204 · Trinity Laboratories, Inc. · Aug 1992
DRESSING CHANGE TRAY, STERILE, DISPOSABLE
K921394 · Trinity Laboratories, Inc. · Aug 1992
DISPOSABLE O.R. TOWEL, STERILE
K915740 · American Threshold Industries, Inc. · Jun 1992
BARRIER DRAPE SHEET WITH SYMETRY FABRIC
K920995 · Johnson & Johnson Medical, Inc. · May 1992
MINOR LACERATION TRAY W/ INSTRUMENT, STERILE, DISP
K920517 · Trinity Laboratories, Inc. · May 1992