Cleared Traditional

K020753 - DEROYAL SURGICAL, UMBILICUP

K020753 is an FDA 510(k) clearance for DEROYAL SURGICAL, manufactured by Deroyal. The device is a Class 2 Hematology device with product code KSR cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K020753 · Deroyal · Hematology device
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Jun 2002
Decision
98d
Days
Class 2
Risk

K020753 is an FDA 510(k) clearance for the DEROYAL SURGICAL, UMBILICUP. Classified as Container, Empty, For Collection & Processing Of Blood & Blood Components (product code KSR), Class II - Special Controls.

Submitted by Deroyal (Powell, US). The FDA issued a Cleared decision on June 13, 2002 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.9100 - the FDA hematology 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Deroyal devices

FDA 510(k) Submission Details - K020753

510(k) Number K020753 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 2002
Decision Date June 13, 2002
Days to Decision 98 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 113d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KSR Device Classification - Class 2, Special Controls

Product Code KSR Container, Empty, For Collection & Processing Of Blood & Blood Components
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.9100
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 Hematology devices follow this clearance model.

Regulatory Peers - KSR Container, Empty, For Collection & Processing Of Blood & Blood Components

All 9
Devices cleared under the same product code (KSR) and FDA review panel - the closest regulatory comparables to K020753.
BLOOD FREEZING BAG
K810500 · Delmed, Inc. · Sep 1981
PLASMA FLEX
K811523 · Terumo America, Inc. · Sep 1981
HAEMONETICS 1000ML COMPONENT BAG
K811449 · Haemonetics Corp. · Jul 1981
HAEMONETICS 600 ML. COMPONENT BAG
K810711 · Haemonetics Corp. · May 1981
HAEMONETICS 1400 ML THERAPEUTIC BAG
K810313 · Haemonetics Corp. · Mar 1981
GAMBRO HEMOFREEZE-BAG
K801082 · Gambro, Inc. · Oct 1980