Cliniguard
FDA 510(k) K800527 · Clinipad Corp.
510(k) numberK800527
Submission
- Device name
- Cliniguard
- Applicant
- Clinipad Corp.
Mchenry, IL, US - Received
- March 7, 1980
- Decision date
- May 8, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KMF – Bandage, Liquid
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 880.5090
- Specialty
- General Hospital
Other 510(k)s with product code KMF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241916 | TearRepair Liquid Skin ProtectantKMF · Traditional | Optmed, Inc. | 09/27/2024SE |
| K182733 | Rochal Bioshield Silicone FilmKMF · Traditional | Rochal Industries, LLC | 06/27/2019SE |
| K171148 | Aleo BME Liquid BandageKMF · Traditional | Aleo Bme, Inc. | 01/12/2018SE |
| K153571 | Cavilon Advanced High Endurance Skin ProtectantKMF · Traditional | 3M Healthcare | 08/23/2016SE |
| K160684 | Atteris No-Sting Skin ProtectantKMF · Traditional | Rochal Industries, LLC | 07/26/2016SE |
| K131384 | Kericure Advanced Liquid Bandage, Natural Seal Liquid Bandage, Liquid BandageKMF · Traditional | Kericure, Inc. | 08/07/2014SE |
| K133443 | Marathon No Sting Liquid Skin ProtectantKMF · Traditional | Advanced Medical Solutions (Plymouth), Ltd. | 07/10/2014SE |
| K120059 | Liquid BandageKMF · Traditional | Chesson Laboratory Associates, Inc. | 05/17/2012SE |
| K092712 | Skin Barrier FilmKMF · Traditional | Lodestar Products, Inc. | 02/23/2010SE |
| K083087 | EcocelKMF · Traditional | Polichem S.A | 08/07/2009SE |
More from Polichem S.A
| 510(k) | Device | Decision |
|---|---|---|
| K931560 | Cardiac Catheterization TrayDQO · Traditional | 07/11/1994SEKD |
| K931668 | Picc Insertion TrayFOZ · Traditional | 03/07/1994SEKD |
| K932071 | I.V. Start KitFOZ · Traditional | 02/17/1994SEKD |
| K932010 | V.A.D. Access KitLJT · Traditional | 02/03/1994SE |
| K932036 | Laceration TrayFRG · Traditional | 12/13/1993SESK |
| K932016 | Tracheostomy Care TrayJOH · Traditional | 11/03/1993SE |
| K862562 | Punch Biopsy KitKNW · Traditional | 10/07/1986SE |
| K862563 | Tracheostomy Cleansing SolutionEPE · Traditional | 07/15/1986SE |
| K833075 | Wet Dressing KitKDD · Traditional | 01/27/1984SE |
| K833432 | Catheter Insertion KitKOD · Traditional | 12/28/1983SE |
Questions and answers
When was Cliniguard cleared by the FDA?
Cliniguard (K800527) received a 510(k) decision of Substantially Equivalent on May 8, 1980, 62 days after the submission was received.
What is the product code of K800527?
The FDA product code is KMF – Bandage, Liquid, a Class I (low risk) device regulated under 21 CFR 880.5090.