I.V. Tape Down Holder
FDA 510(k) K800024 · Consolidated Medical Equipment, Inc.
510(k) numberK800024
Submission
- Device name
- I.V. Tape Down Holder
- Applicant
- Consolidated Medical Equipment, Inc.
Mchenry, IL, US - Received
- January 7, 1980
- Decision date
- January 29, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K935252 | K-Lok Catheter Securement Device ModificationKMK · Traditional | K-Lok, Inc. | 02/18/1994SE |
More from K-Lok, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K854040 | I.V. DressingKMK · Traditional | 01/09/1986SE |
| K850132 | Disposable Conductive Adhesive Diagnostic ECG ElecDRX · Traditional | 04/09/1985SE |
| K850130 | PRN ECG ElectrodeDRX · Traditional | 04/09/1985SE |
| K850037 | Closed Wound DrainGCY · Traditional | 03/19/1985SE |
| K844942 | Plura-Gard Chest Drainage SystemKDQ · Traditional | 03/12/1985SE |
| K850311 | Dispos. Conductive Adhesive TENS PadGXY · Traditional | 03/05/1985SE |
| K850131 | Conductive Adhesive Post-Op Electrode-TensGXY · Traditional | 03/05/1985SE |
| K850133 | Veni-Gard Ap & TPN, Derma-Shield, Derma-Shield Jr.KGX · Traditional | 02/28/1985SE |
| K850129 | Modified Conductive Adhesive Electrosurgical GrounGEI · Traditional | 02/28/1985SE |
| K844372 | Hand Controlled Electrosurgical Pencil DisposableGEI · Traditional | 02/21/1985SE |
Questions and answers
When was I.V. Tape Down Holder cleared by the FDA?
I.V. Tape Down Holder (K800024) received a 510(k) decision of Substantially Equivalent on January 29, 1980, 22 days after the submission was received.
What is the product code of K800024?
The FDA product code is KMK – Device, Intravascular Catheter Securement, a Class I (low risk) device regulated under 21 CFR 880.5210.