K-Lok Catheter Securement Device Modification
FDA 510(k) K935252 · K-Lok, Inc.
510(k) numberK935252
Submission
- Device name
- K-Lok Catheter Securement Device Modification
- Applicant
- K-Lok, Inc.
Boca Raton, FL, US - Received
- October 7, 1993
- Decision date
- February 18, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KMK – Device, Intravascular Catheter Securement
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5210
- Specialty
- General Hospital
Other 510(k)s with product code KMK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K180994 | SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath…KMK · Traditional | Interrad Medical, Inc. | 07/09/2019SE |
| K981860 | A P HarnessKMK · Traditional | Paraworks Enterprise, Ltd. | 06/03/1999SE |
| K963365 | Multi-Purpose Medical Tube HolderKMK · Traditional | Byrd Medical Devices, Inc. | 10/11/1996SE |
| K941098 | Secure-SiteKMK · Traditional | Op-Co Medical Products , Ltd. | 08/09/1995SE |
| K943147 | Statlock CVKMK · Traditional | Venetec, Inc. | 09/29/1994SE |
| K943047 | IV Start KitsKMK · Traditional | Sterile Concepts, Inc. | 09/14/1994SE |
| K941940 | Immobile Sterile and Immobile A/C SterileKMK · Traditional | Tnt Moborg Intl. , Ltd. | 07/14/1994SE |
| K941850 | Immobile Non-Sterile and Immobile A/C Non-SterileKMK · Traditional | Tnt Moborg Intl. , Ltd. | 07/14/1994SE |
| K935389 | Conmed Veni-Gard I.V. DressingKMK · Traditional | Conmedcorp | 03/07/1994SE |
| K940127 | Centermark Securing WingsKMK · Traditional | Menlo Care, Inc. | 02/09/1994SE |
More from Menlo Care, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K930225 | K-Lok Catheter Securement DeviceKMK · Traditional | 04/21/1993SE |
Questions and answers
When was K-Lok Catheter Securement Device Modification cleared by the FDA?
K-Lok Catheter Securement Device Modification (K935252) received a 510(k) decision of Substantially Equivalent on February 18, 1994, 134 days after the submission was received.
What is the product code of K935252?
The FDA product code is KMK – Device, Intravascular Catheter Securement, a Class I (low risk) device regulated under 21 CFR 880.5210.