Dale I.V. Connect. Lock & Stabilizer (STABILOK)220
FDA 510(k) K873311 · Dale Medical Products, Inc.
510(k) numberK873311
Submission
- Device name
- Dale I.V. Connect. Lock & Stabilizer (STABILOK)220
- Applicant
- Dale Medical Products, Inc.
Plainville, MA, US - Received
- August 17, 1987
- Decision date
- November 5, 1987
- 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 |
|---|---|---|
| K082241 | The Dale Ace Connector (Access Controller for Enteral), Model H84104751KNT · Traditional | 10/30/2008SE |
| K994300 | Nasogastric Tube Holder, Model 160KNT · Traditional | 02/10/2000SE |
| K964399 | Dale Endotracheal Tube Holder 270/280CBH · Traditional | 01/28/1997SE |
| K961693 | Dale Gastrostomy Tube HolderPLI · Traditional | 07/30/1996SE |
| K951491 | Dale Tracheostomy Tube Holder with Trach Mask Attachment TabsCBH · Traditional | 04/24/1995SE |
| K914245 | Dale(R) Nasal Dressing Holder (Product No. 600)KGX · Traditional | 12/09/1991SE |
| K905231 | Dale Ventilator Tubing Support for Trach. Vent.CBH · Traditional | 01/14/1991SE |
| K894586 | Dale I.V. Identifier; Product #1125KMK · Traditional | 08/15/1989SE |
| K864897 | Dale Venipuncture Tourniquet, Product No. 1335GAX · Traditional | 01/12/1987SE |
| K860583 | Dale Head Band Anesthesia Circuit Tube Holder 1315JAY · Traditional | 02/21/1986SE |
Questions and answers
When was Dale I.V. Connect. Lock & Stabilizer (STABILOK)220 cleared by the FDA?
Dale I.V. Connect. Lock & Stabilizer (STABILOK)220 (K873311) received a 510(k) decision of Substantially Equivalent on November 5, 1987, 80 days after the submission was received.
What is the product code of K873311?
The FDA product code is KMK – Device, Intravascular Catheter Securement, a Class I (low risk) device regulated under 21 CFR 880.5210.