← Product Code QSY · K072474 # QUIKCLOT EX (K072474) _Z-Medica Corporation · QSY · Oct 16, 2007 · SU · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K072474 ## Device Facts - **Applicant:** Z-Medica Corporation - **Product Code:** QSY - **Decision Date:** Oct 16, 2007 - **Decision:** SESE - **Submission Type:** Traditional - **Device Class:** Class U - **Review Panel:** SU - **Attributes:** Therapeutic ## Intended Use Prescription Use: QuikClot® eX™ is intended for temporary external use to control traumatic bleeding. Over-The-Counter Use: QuikClot® eX™ is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions. ## Device Story QuikClot® eX™ is a hemostatic gauze sponge consisting of non-woven medical gauze impregnated with Kaolin (clay mineral) bound by Glycerin. Designed for temporary external use to control bleeding; functions by promoting hemostasis via Kaolin contact. Unlike earlier granular hemostatic agents, this design avoids heat generation and burn risks. Packaged as a 4" x 4" four-ply square in a foil pouch; sterilized via irradiation. Used in clinical or first-aid settings to manage traumatic or minor wounds; applied directly to the bleeding site by clinicians or lay users. Benefits include rapid clot formation compared to untreated dressings, facilitating hemorrhage control. ## Clinical Evidence Bench and animal testing provided. In-vitro testing demonstrated faster clotting of whole sheep's blood compared to untreated controls. In-vivo swine model testing showed effectiveness in controlling femoral vessel transection and bleeding from liver, spleen, and mesenteric injuries. Biocompatibility confirmed via four separate laboratory tests. ## Technological Characteristics Non-woven medical gauze substrate; Kaolin mineral active agent; Glycerin binder. 4" x 4" four-ply square form factor. Sterilized via irradiation (SAL 10^-6). Foil pouch packaging. No electronic components or software. ## Regulatory Identification To temporarily control bleeding and cover external wounds. ## Predicate Devices - QuikClot® Hemostatic Agent ([K013390](/device/K013390.md)) - QuikClot® Sport™ ([K070010](/device/K070010.md)) - Nu Gauze® All Purpose Dressing ([K821150](/device/K821150.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. June 11, 2023 Z-Medica Corporation Ronald Peterson Director of RA/QA 4 Fairfield Boulevard Wallingford, Connecticut 06492 Re: K072474 Trade/Device Name: QuikClot® eXTM Regulatory Class: Unclassified Product Code: QSY Dear Ronald Peterson: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated October 16, 2007. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code QSY. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Julie Morabito, OHT4: Office of Surgical and Infection Control Devices, 240-402-3839, Julie.Morabito@fda.hhs.gov. Image /page/0/Picture/7 description: The image shows the signature block of Julie A. Morabito, Ph.D., Assistant Director at the FDA. The signature block includes her name, title, and the name of her division and office. The division is DHT4B: Division of Infection Control and Plastic Surgery Devices, and the office is OHT4: Office of Surgical and Infection Control Devices. The signature block also includes the Office of Product Evaluation and Quality. Center for Devices and Radiological Health {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird with its wings spread, rendered in a simple, abstract design. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 OCT 16 2007 Re: K072474 Z-Medica Corporation % Mr. Ronald Peterson Director of RA/QA 4 Fairfield Boulevard Wallingford, Connecticut 06492 Trade/Device Name: QuikClot® eX™ Regulatory Class: Unclassified Product Code: FRO Dated: October 1, 2007 Received: October 2, 2007 Dear Mr. Peterson: 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 is 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); 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. {2}------------------------------------------------ Page 2 -- Mr. Ronald Peterson This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours. For P.B. Now Mark N. Melkerson DE P.E. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Indications For Use K072474 510(k) Number (if known): Device Trade Names: QuikClot® eX™ Device Common Name: Hemostatic Gauze Sponge Indications For Use: Prescription Use QuikClot® eX™ is intended for temporary external use to control traumatic bleeding. Over-The-Counter Use QuikClot® eXT™ is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart C) Image /page/3/Picture/12 description: The image contains a square box with a check mark inside. The check mark is thick and black, and it fills most of the box. The box is also black and has a thick border. The check mark indicates that a selection has been made. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Division Sign-Off Oivision of General, Restorative, and Neurological Devices Number ***_***__ `/072474 Page 1 {4}------------------------------------------------ Page 1 of 1 # 510(k) Summary - K072474 | Trade Name: | QuikClot® eX™ | |-----------------------|----------------------------------------------------------------------------------------------------------------| | Device Class: | Class 1 | | Classification Panel: | General and Plastic Surgery | | Common Name: | Hemostatic Gauze Sponge | | Classification Name: | Dressing | | Classification Code: | FRO | | Predicate Device(s): | QuikClot® Hemostatic Agent (K013390)
QuikClot® Sport™ (K070010)
Nu Gauze® All Purpose Dressing (K821150) | | Submitted By: | Ronald E. Peterson, Dir. of Regulatory Affairs and QA | | Company Name: | Z-Medica Corporation | | Company Address: | 4 Fairfield Blvd., Wallingford, CT 06492 | | Company Phone: | +1-203-294-0000 x262 | | Prepared: | August 31, 2007 | | Revised: | October 4, 2007 | ### Description of Device QuikClot® eX™ consists of standard non-woven medical gauze that has a clay mineral (Kaolin) bound to the gauze with Glycerin. Kaolin promotes hemostasis in a similar mechanism as QuikClot® Hemostatic Agent (K013390), but without the associated heat generation and risk of burning. QuikClot® eX™ is packaged as a four ply square sponge 4" x 4" sealed in a foil pouch and irradiated to a SAL of 10-6. The foil package has the same material composition and construction as the QuikClot® Hemostatic Agent package. #### Intended Use of Device Prescription Use: QuikClot® eX™ is intended for temporary external use to control traumatic bleeding. Over-The-Counter Use: QuikClot® eX™ is intended for temporary external use to stop bleeding of superficial wounds, minor cuts, and abrasions. ## Discussion of Data to Support Substantial Equivalence QuikClot® eX™ has been proven to clot whole sheep's blood faster than untreated controls during in-vitro testing, and has proven to be more effective during in-vivo testing of the swine model transection of the femoral vessels than untreated controls. QuikClot® eX™ has also proven to be effective in stopping bleeding of liver, spleen and mesenteric injuries, and has been successfully tested for biocompatibility in four separate laboratory tests. #### Conclusion Based on the in-vitro and in-vivo test data, and the biocompatibility data, QuikClot® eX™ is substantially equivalent in efficacy to the predicate devices (QuikClot® Hemostatic Agent (K013390) & QuikClot® Sport™ (K070010)) and in safety to Nu Gauze® All Purpose Dressing (K821150) and QuikClot® Sport™ (K070010). --- **Source:** [https://fda.innolitics.com/device/K072474](https://fda.innolitics.com/device/K072474) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com