FDA product code KOZ: Beads, Hydrophilic, For Wound Exudate Absorption
KOZ is the FDA product code for beads, hydrophilic, for wound exudate absorption. It is a Class I device, regulated under 21 CFR 878.4018 and reviewed by the General and Plastic Surgery panel. FDA has cleared 22 510(k) submissions under KOZ, from 16 different applicants. The average 510(k) review took 110 days (median 86).
Classification
| Field | Value |
|---|---|
| Device name | Beads, Hydrophilic, For Wound Exudate Absorption |
| Device class | Class I |
| Regulation | 21 CFR 878.4018 |
| 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 KOZ clearance
Top KOZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Smith & Nephew United, Inc. | 3 | 1990-10-23 |
| Hollister, Inc. | 2 | 1991-04-12 |
| Perstorp AB C/O Robert Joel Slomoff | 2 | 1991-01-31 |
| Marion Laboratories, Inc. | 2 | 1988-01-22 |
| Pharmaseal Laboratories | 2 | 1980-08-04 |
11 more applicants have KOZ clearances. See the full list in Caduvo.
Most recent KOZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K905206 | Hollister, Inc. | INCARE PINSITE DRESSING | 1991-04-12 | 143 |
| K905688 | Beiersdorf, Inc. | CUTINOVA HYDRO | 1991-04-01 | 103 |
| K905069 | Perstorp AB C/O Robert Joel Slomoff | IODOSORB GEL | 1991-01-31 | 83 |
| K904604 | Fountain Pharmaceuticals, Inc. | REDI-RELEASE ABSORBENT DRESSING | 1991-01-07 | 89 |
| K903645 | Convatec, A Division of E.R. Squibb & Sons | DERMASORB WOUND CONTACT LAYER DRESSING | 1990-11-21 | 99 |
Recalls for KOZ devices
openFDA lists no recalls for product code KOZ.
Frequently asked questions
What is FDA product code KOZ?
KOZ is the FDA product code for beads, hydrophilic, for wound exudate absorption. It is a Class I device, regulated under 21 CFR 878.4018 and reviewed by the General and Plastic Surgery panel.
What device class is KOZ?
Class I, regulation 21 CFR 878.4018. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KOZ?
Across 22 cleared submissions the average was 110 days from receipt to decision (median 86).
Which companies have the most KOZ clearances?
Smith & Nephew United, Inc. (3); Hollister, Inc. (2); Perstorp AB C/O Robert Joel Slomoff (2); Marion Laboratories, Inc. (2); Pharmaseal Laboratories (2).
Next steps
- Run an FDA pathway report with predicate devices for product code KOZ
- Run a recall and safety report across every KOZ manufacturer
- Watch product code KOZ 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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