Quickclot
FDA 510(k) K013390 · On Site Gas Systems, Inc.
510(k) numberK013390
Submission
- Device name
- Quickclot
- Applicant
- On Site Gas Systems, Inc.
Newington, CT, US - Received
- October 15, 2001
- Decision date
- May 23, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Expedited review
- Yes
Device classification
- Product code
- QSY – Hemostatic Wound Dressing Without Thrombin Or Other Biologics
- Device class
- Unclassified
To temporarily control bleeding and cover external wounds.
Other 510(k)s with product code QSY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253017 | BloodSTOP iX Trauma Matrix (TM-iX-20)QSY · Traditional | Lifescience Plus, Inc. | 04/30/2026SE |
| K251700 | Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x 10cm…QSY · Traditional | Speciality Fibres and Materials Limited | 02/26/2026SE |
| K250319 | Mfuse (MS001)QSY · Traditional | Machina Medical, Inc. | 12/15/2025SE |
| K253609 | TRAUMAGEL® 2.0 Hemostatic GelQSY · Special | Cresilon, Inc. | 12/12/2025SE |
| K240713 | Traumagel®QSY · Traditional | Cresilon, Inc. | 08/14/2024SE |
| K240097 | Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)QSY · Traditional | Ushare Medical, Inc. | 05/22/2024SE |
| K232216 | Hemoblock_S (Prescription); Hemoblock_S (OTC)QSY · Traditional | Incore Co., Ltd. | 04/19/2024SE |
| K240454 | RESPONDER® Polysaccharide HemostatQSY · Special | Starch Medical, Inc. | 03/15/2024SE |
| K220525 | RESPONDER Polysaccharide HemostatQSY · Traditional | Starch Medical, Inc. | 12/04/2023SE |
| K230589 | Celox Rapid X-Ray GauzeQSY · Traditional | Medtrade Products , Ltd. | 11/17/2023SE |
More from Medtrade Products , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K092636 | Pogs, Model 65/130CAW · Traditional | 01/07/2010SE |
| K063454 | Pogs, Model 33CCAW · Traditional | 05/09/2007SE |
| K041664 | Portable Oxygen Generation System: Pogs 33CCAW · Traditional | 07/29/2004SE |
| K030920 | Pogs 33CAW · Traditional | 03/10/2004SE |
| K021581 | HemosorbQSY · Traditional | 07/12/2002SE |
| K021082 | On Site Gas Systems Portable Oxygen Generation SYSTEM-1.0 and 5.0CAW · Traditional | 05/22/2002SE |
| K020362 | P.O.G.S. 3.3 Portable Oxygen Generator SystemCAW · Traditional | 02/12/2002SE |
| K014078 | On Site Gas Systems Portable Oxygen Generator SystemCAW · Traditional | 01/08/2002SE |
Questions and answers
When was Quickclot cleared by the FDA?
Quickclot (K013390) received a 510(k) decision of Substantially Equivalent on May 23, 2002, 220 days after the submission was received.
What is the product code of K013390?
The FDA product code is QSY – Hemostatic Wound Dressing Without Thrombin Or Other Biologics, a Unclassified device.