Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart F — General Hospital and Personal Use Therapeutic Devices](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices) → [21 CFR 880.5210](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5210) → KMK — Device, Intravascular Catheter Securement # KMK · Device, Intravascular Catheter Securement _General Hospital · 21 CFR 880.5210 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMK ## Overview - **Product Code:** KMK - **Device Name:** Device, Intravascular Catheter Securement - **Regulation:** [21 CFR 880.5210](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/880.5210) - **Device Class:** 1 - **Review Panel:** [General Hospital](/submissions/HO) ## Identification An intravascular catheter securement device is a device with an adhesive backing that is placed over a needle or catheter and is used to keep the hub of the needle or the catheter flat and securely anchored to the skin. ## Classification Rationale Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. ## Recent Cleared Devices (20 of 64) Showing 20 most recent of 64 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K180994](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMK/K180994.md) | SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F | Interrad Medical, Inc. | Jul 9, 2019 | SESE | | [K981860](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMK/K981860.md) | A P HARNESS | Paraworks Enterprise, Ltd. | Jun 3, 1999 | SESE | | [K963365](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMK/K963365.md) | MULTI-PURPOSE MEDICAL TUBE HOLDER | Byrd Medical Devices, Inc. | Oct 11, 1996 | SESE | | [K941098](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMK/K941098.md) | SECURE-SITE | Op-Co Medical Products , Ltd. | Aug 9, 1995 | SESE | | [K943147](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMK/K943147.md) | STATLOCK CV | Venetec, Inc. | Sep 29, 1994 | SESE | | [K943047](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMK/K943047.md) | IV START KITS | Sterile Concepts, Inc. | Sep 14, 1994 | SESE | | [K941940](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMK/K941940.md) | IMMOBILE STERILE AND IMMOBILE A/C STERILE | Tnt Moborg Intl. , Ltd. | Jul 14, 1994 | SESE | | [K941850](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMK/K941850.md) | IMMOBILE NON-STERILE AND IMMOBILE A/C NON-STERILE | Tnt Moborg Intl. , Ltd. | Jul 14, 1994 | SESE | | [K935389](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMK/K935389.md) | CONMED VENI-GARD I.V. DRESSING | Conmedcorp | Mar 7, 1994 | SESE | | [K935252](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMK/K935252.md) | K-LOK CATHETER SECUREMENT DEVICE MODIFICATION | K-Lok, Inc. | Feb 18, 1994 | SESE | | [K940127](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMK/K940127.md) | CENTERMARK SECURING WINGS | Menlo Care, Inc. | Feb 9, 1994 | SESE | | [K932757](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMK/K932757.md) | SECURODRIP (TM) I.V. ARMBOARD | Op-Co Medical Products , Ltd. | Dec 8, 1993 | SESE | | [K925992](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMK/K925992.md) | DUODERM TRANSPARENT HYDROCOLLOID DRESSING | Convatec, A Division of E.R. Squibb & Sons | Oct 15, 1993 | SESE | | [K930663](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMK/K930663.md) | IV COMFORT PAD | D.J. Scott Mfg., Inc. | Sep 30, 1993 | SESE | | [K922103](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMK/K922103.md) | IAB ANCHOR | Datascope Corp. | Aug 3, 1993 | SESE | | [K930225](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMK/K930225.md) | K-LOK CATHETER SECUREMENT DEVICE | K-Lok, Inc. | Apr 21, 1993 | SESE | | [K930197](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMK/K930197.md) | KWIK BOARD | Astral, Ltd. | Apr 20, 1993 | SESE | | [K924180](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMK/K924180.md) | I.V. PRO | I.V. - Pro Tek, Inc. | Mar 16, 1993 | SESE | | [K924369](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMK/K924369.md) | ILS(TM) - INVASIVE LINE SEPARATOR | 2-Rn Corp. | Feb 5, 1993 | SESE | | [K924249](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMK/K924249.md) | DERMASSIST TRANSPARENT SITE DRESSING | Wilshire Medical Products | Feb 3, 1993 | SESE | ## Top Applicants - Ansley Medical Products, Inc. — 3 clearances - Op-Co Medical Products , Ltd. — 3 clearances - Consolidated Medical Equipment, Inc. — 2 clearances - Dale Medical Products, Inc. — 2 clearances - K-Lok, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMK](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMK) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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