Cleared Traditional

K842644 - TPN/HYPERALIMENTATION TRAY

K842644 is an FDA 510(k) clearance for TPN/HYPERALIMENTATION TRAY, manufactured by Deroyal Industries, Inc.. The device is a Class 2 General Hospital device with product code FRG cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K842644 · Deroyal Industries, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1984
Decision
121d
Days
Class 2
Risk

K842644 is an FDA 510(k) clearance for the TPN/HYPERALIMENTATION TRAY. Classified as Wrap, Sterilization (product code FRG), Class II - Special Controls.

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on November 8, 1984 after a review of 121 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6850 - 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 - K842644

510(k) Number K842644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1984
Decision Date November 08, 1984
Days to Decision 121 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 129d · This submission: 121d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRG Device Classification - Class 2, Special Controls

Product Code FRG Wrap, Sterilization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6850
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 - FRG Wrap, Sterilization

All 231
Devices cleared under the same product code (FRG) and FDA review panel - the closest regulatory comparables to K842644.
KIMGUARD PROCEDURE TRAY
K852203 · Kimberly-Clark Corp. · Jun 1985
ABCO INSTRUMENT PACKS & TRAYS
K851315 · Abco Dealers, Inc. · May 1985
BLUE SEAL II STERILIZATION POUCH
K851340 · American Sterilizer Co. · Apr 1985
O.B. BASIN SET
K843982 · Pro-Lab, Inc. · Oct 1984
SKIN SCRUB TRAY STERILE SKIN SCRUB KIT
K842490 · Biological & Environmental Control Laboratories · Aug 1984
DR. GOULD HAND PACK SUSTOM STERIL
K842405 · Pro-Lab, Inc. · Aug 1984