Cleared Traditional

K842627 - C-SECTION TRAY

K842627 is the FDA 510(k) clearance for C-SECTION TRAY by Deroyal Industries, Inc.. It is a Class 1 General & Plastic Surgery device (product code KDD) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K842627 · Deroyal Industries, Inc. · General & Plastic Surgery device
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Sep 1984
Decision
82d
Days
Class 1
Risk

K842627 is an FDA 510(k) clearance for the C-SECTION TRAY. Classified as Kit, Surgical Instrument, Disposable (product code KDD), Class I - General Controls.

Submitted by Deroyal Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 26, 1984 after a review of 82 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Deroyal Industries, Inc. devices

Submission Details

510(k) Number K842627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 1984
Decision Date September 26, 1984
Days to Decision 82 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 115d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KDD Kit, Surgical Instrument, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - KDD Kit, Surgical Instrument, Disposable

All 18
Devices cleared under the same product code (KDD) and FDA review panel - the closest regulatory comparables to K842627.
MEGA GENERAL PURPOSE INSTRUMENT KIT
K910366 · Megadyne Medical Products, Inc. · Mar 1991
INCISION AND DRAINAGE KIT
K910369 · Megadyne Medical Products, Inc. · Mar 1991
ENTERON ABDOMINAL PARACENTESIS TRAY
K874063 · Endovations · Dec 1987
STERILE SUTURE BOOTS
K834135 · Devon Industries, Inc. · Apr 1984
FIRST AID KITS
K831795 · I M, Inc. · Sep 1983
ACKRAD INCISION & DRAIN SET
K813103 · Ackrad Laboratories · Dec 1981