FDA product code KDH: Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration
KDH is the FDA product code for catheter (gastric, colonic, etc.), irrigation and aspiration. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 23 510(k) submissions under KDH, from 17 different applicants. The average 510(k) review took 146 days (median 93). FDA has posted 2 recalls for KDH devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Catheter (Gastric, Colonic, Etc.), Irrigation And Aspiration |
| Device class | Class II |
| Regulation | 21 CFR 876.5980 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every KDH clearance
Top KDH applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Autovage | 4 | 1992-04-13 |
| Ethox Corp. | 2 | 1997-02-21 |
| Tri-Med Specialties, Inc. | 2 | 1992-09-04 |
| Sherwood Medical Industries | 2 | 1977-03-09 |
| Giltech Plus, Inc. | 1 | 1999-03-18 |
12 more applicants have KDH clearances. See the full list in Caduvo.
Most recent KDH clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K983624 | Giltech Plus, Inc. | GILTECH PLUS CONNECTING TUBE SET | 1999-03-18 | 154 |
| K981286 | Armm, Inc. | SUPERFLOW IRRIGATION AND ASPIRATION TUBING SETS | 1998-06-19 | 72 |
| K971259 | B.Braun Medical, Inc. | COMBIPORT FLUID LAVAGE DEVICE | 1997-10-27 | 206 |
| K962850 | Ethox Corp. | TUM-E-VAC | 1997-02-21 | 214 |
| K951533 | Ballard Medical Products | EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT | 1995-07-05 | 93 |
Recalls for KDH devices
2 product recalls in 2 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2024-02-23.
| Year | Recalls |
|---|---|
| 2024 | 1 |
Frequently asked questions
What is FDA product code KDH?
KDH is the FDA product code for catheter (gastric, colonic, etc.), irrigation and aspiration. It is a Class II device, regulated under 21 CFR 876.5980 and reviewed by the Gastroenterology and Urology panel.
What device class is KDH?
Class II, regulation 21 CFR 876.5980. Typical premarket route: 510(k).
How long does a 510(k) take for product code KDH?
Across 23 cleared submissions the average was 146 days from receipt to decision (median 93).
Which companies have the most KDH clearances?
Autovage (4); Ethox Corp. (2); Tri-Med Specialties, Inc. (2); Sherwood Medical Industries (2); Giltech Plus, Inc. (1).
Have KDH devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2024-02-23.
Next steps
- Run an FDA pathway report with predicate devices for product code KDH
- Run a recall and safety report across every KDH manufacturer
- Watch product code KDH for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Gastroenterology and Urology product codes · FDA product code lookup · 510(k) database search · 510(k) review times