Vaccines, Blood & Biologics

BK090031 Letter

July 23, 2009

Fenwal, Incorporated 
Attention: Tammy Davis
Regulatory Affairs Specialist
Three Corporate Drive
Lake Zurich, Illinois 60047

Re: BK090031

Device Name: (4R2105) Bone Marrow Collection Stand
(4R2107H) Bone Marrow Collection Kit with Flexible Pre-Filter and Inline Filters
(4R2108H) Ancillary Bone Marrow Collection Container with Flexible Pre-Filter
Regulation Name: Bone Marrow Collection/Transfusion Kit
Regulatory Class: Unclassified
Product Code: LWE
Dated: June 19, 2009
Received: June 23, 2009

Dear Ms. Davis:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device has been classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA’s issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act’s requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice on promotional labeling and advertisement for your device, please contact our Advertising and Promotional Labeling Staff (HFM-602) at (301) 827-3028. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to for the CDRH’s Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address:

Sincerely yours,


Celia M. Witten, Ph.D., M.D.
Office of Cellular, Tissue and Gene Therapies
Center for Biologics Evaluation and Research


Indications for Use

510(k) Number: BK090031

Device Name:

(4R2105) Bone Marrow Collection Stand

(4R2107H) Bone Marrow Collection Kit with Flexible Pre-Filter and Inline Filters

(4R2108H) Ancillary Bone Marrow Collection Container with Flexible Pre-Filter

Indications for Use:

The Bone Marrow Collection Kit, Ancillary Container, and Bone Marrow Collection Stand are used for the collection and filtration of aspirated bone marrow in preparation for bone marrow transplantation.

Page Last Updated: 08/07/2009
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