← Product Code [KMK](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMK) · K935252

# K-LOK CATHETER SECUREMENT DEVICE MODIFICATION (K935252)

_K-Lok, Inc. · KMK · Feb 18, 1994 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMK/K935252

## Device Facts

- **Applicant:** K-Lok, Inc.
- **Product Code:** [KMK](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMK.md)
- **Decision Date:** Feb 18, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 880.5210
- **Device Class:** Class 1
- **Review Panel:** General Hospital

## Regulatory 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.

---

**Source:** [https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMK/K935252](https://fda.innolitics.com/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/KMK/K935252)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com
