Product Code: KSR FDA class 2 21 CFR 864.9100

Container, Empty, For Collection & Processing Of Blood & Blood Components

Hematology

This device is an empty container used for the collection and processing of blood and blood components, including bags and associated tubing sets intended to hold whole blood, red cells, plasma, or platelets during collection, preparation, or storage for transfusion. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KSR, regulated under 21 CFR 864.9100 within the Hematology specialty. No special flags apply.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code KSR in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: KSR
Device Class: FDA class 2
Regulation Number: 864.9100
Medical Specialty: Hematology
Review Panel: HE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 16 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K032827	KENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501	Dec 08, 2003	Substantially Equivalent	Tyco Healthcare
K020753	DEROYAL SURGICAL, UMBILICUP	Jun 13, 2002	Substantially Equivalent	Deroyal
K810897	ALPHA PLASTIC PLASMA BOTTLE	Sep 23, 1981	Substantially Equivalent	Alpha Therapeutic Corp.
K810500	BLOOD FREEZING BAG	Sep 23, 1981	Substantially Equivalent	Delmed, Inc.
K811523	PLASMA FLEX	Sep 09, 1981	Substantially Equivalent	Terumo America, Inc.
K811449	HAEMONETICS 1000ML COMPONENT BAG	Jul 01, 1981	Substantially Equivalent	Haemonetics Corp.
K810711	HAEMONETICS 600 ML. COMPONENT BAG	May 08, 1981	Substantially Equivalent	Haemonetics Corp.
K810313	HAEMONETICS 1400 ML THERAPEUTIC BAG	Mar 31, 1981	Substantially Equivalent	Haemonetics Corp.
K801219	PLASMAPOOLER	Oct 31, 1980	Substantially Equivalent	North American Biologicals, Inc.
K801082	GAMBRO HEMOFREEZE-BAG	Oct 31, 1980	Substantially Equivalent	Gambro, Inc.
K792395	PHARMAFLEX CRYOGENIC BAG	Feb 26, 1980	Substantially Equivalent	Pharmachem Corp.
K792185	PIASMA SAFE	Dec 28, 1979	Substantially Equivalent	Cry-O-Safe, Inc.
K791673	EMPTY TRANSFER BAG	Oct 23, 1979	Substantially Equivalent	Delmed, Inc.
K781811	TRANSFER PAK 4R 9006	Nov 08, 1978	Substantially Equivalent	Travenol Laboratories, S.A.
K780354	CRYOCYTE PACK	Jun 14, 1978	Substantially Equivalent	Travenol Laboratories, S.A.
K760952	TERASAKI LYMPHOCYTE TRANSPORT KIT	Jan 17, 1977	Substantially Equivalent	Dravon Medical, Inc.