FDA product code KGZ: Accessories, Catheter
KGZ is the FDA product code for accessories, catheter. It is a Class I device, regulated under 21 CFR 878.4200 and reviewed by the General and Plastic Surgery panel. FDA has cleared 29 510(k) submissions under KGZ, from 23 different applicants. The average 510(k) review took 52 days (median 41). FDA has posted 23 recalls for KGZ devices, 4 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Accessories, Catheter |
| Device class | Class I |
| Regulation | 21 CFR 878.4200 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KGZ clearance
Top KGZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| B. Braun Instruments | 3 | 1976-11-02 |
| Warner-Lambert Co. | 2 | 1982-06-23 |
| Quinton, Inc. | 2 | 1981-03-24 |
| Arrow Intl., Inc. | 2 | 1980-10-23 |
| Conphar, Inc. | 2 | 1979-09-21 |
18 more applicants have KGZ clearances. See the full list in Caduvo.
Most recent KGZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K022306 | Aesthetic and Reconstructive Technologies, Inc. | AART SILICONE TUBING | 2002-10-10 | 86 |
| K974295 | Byron Medical | BYRON MEDICAL ASPIRATION AND INFILTRATION/IRRIGATION TUBING | 1998-02-10 | 88 |
| K973183 | R & D Medical Products, Inc. | WOUND DRAINAGE HOLDER | 1998-01-23 | 151 |
| K955433 | Allied Biomedical Corp. | DURALASTIC SILICONE TUBING | 1996-01-26 | 59 |
| K942315 | Navarre Biomedical , Ltd. | NAVARRE PERCUTANEOUS ACCESS SET | 1994-07-08 | 56 |
Recalls for KGZ devices
23 product recalls in 17 recall events; 4 initiated in the last five years and 4 still open. Most recent: 2025-10-29.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 5 |
| 2019 | 1 |
| 2020 | 1 |
| 2025 | 4 |
Frequently asked questions
What is FDA product code KGZ?
KGZ is the FDA product code for accessories, catheter. It is a Class I device, regulated under 21 CFR 878.4200 and reviewed by the General and Plastic Surgery panel.
What device class is KGZ?
Class I, regulation 21 CFR 878.4200. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KGZ?
Across 29 cleared submissions the average was 52 days from receipt to decision (median 41).
Which companies have the most KGZ clearances?
B. Braun Instruments (3); Warner-Lambert Co. (2); Quinton, Inc. (2); Arrow Intl., Inc. (2); Conphar, Inc. (2).
Have KGZ devices been recalled?
Yes: 23 product recalls across 17 recall events; the most recent began 2025-10-29.
Next steps
- Run an FDA pathway report with predicate devices for product code KGZ
- Run a recall and safety report across every KGZ manufacturer
- Watch product code KGZ 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.
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