Filtroder Filters
FDA 510(k) K840267 · Coloplast A/S
510(k) numberK840267
Submission
- Device name
- Filtroder Filters
- Applicant
- Coloplast A/S
Mchenry, IL, US - Received
- January 23, 1984
- Decision date
- April 2, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- EXB – Collector, Ostomy
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 876.5900
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code EXB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252140 | Heylo SystemEXB · Traditional | Coloplast Corp. | 10/06/2025SE |
| K181643 | SmartBag (SmartPouch)EXB · Traditional | 11 Health Technologies Limited | 11/16/2018SE |
| K140938 | Ostom-I AlertEXB · Traditional | 11 Health and Technologies, LLC | 10/10/2014SE |
| K922730 | Lake Ostomy Care SetEXB · Traditional | Lake Medical Products, Inc. | 12/30/1993SESK |
| K882878 | Odor-End Emergency Clean Up PowderEXB · Traditional | Cdc Products Corp. | 12/08/1988SE |
| K881636 | Conseal Colostomy Continence System (One-Piece)EXB · Traditional | Coloplast A/S | 07/13/1988SE |
| K880306 | Emergency-Clean Up(Tm) EcpEXB · Traditional | Cdc Products Corp. | 05/20/1988SE |
| K872294 | Combination Nite Drainage UnitEXB · Traditional | Arnold Technologies | 12/29/1987SE |
| K873929 | 'Catch-It' or Fecal Containment DeviceEXB · Traditional | Midwest Medical Co. | 12/03/1987SE |
| K871526 | Odor-Safe(Tm)(Liquid) Odor-Safe(Tm) PowderEXB · Traditional | Cox Family Laboratories, Inc. | 10/13/1987SE |
More from Cox Family Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K262045 | Luja SoftEZD · Special | 07/07/2026SE |
| K221874 | Altis Single Incision Sling SystemPAH · Special | 02/15/2023SE |
| K220420 | Saffron Fixation SystemPBQ · Traditional | 06/10/2022SE |
| K191536 | Biatain Silicone AgFRO · Traditional | 02/21/2020SE |
| K181811 | ReTrace Ureteral Access SheathFED · Special | 09/07/2018SE |
| K173527 | Digitex Delivery DevicePWI · Traditional | 02/12/2018SE |
| K140310 | Peristeen Anal Irrigation SystemKNT · Traditional | 09/03/2015SE |
| K150935 | SpeediCath Compact EveGBM · Traditional | 07/02/2015SE |
| K150927 | Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire…OCY · Traditional | 05/27/2015SE |
| K143182 | Speedicath Compact MaleGBM · Traditional | 01/20/2015SE |
Questions and answers
When was Filtroder Filters cleared by the FDA?
Filtroder Filters (K840267) received a 510(k) decision of Substantially Equivalent on April 2, 1984, 70 days after the submission was received.
What is the product code of K840267?
The FDA product code is EXB – Collector, Ostomy, a Class I (low risk) device regulated under 21 CFR 876.5900.