FDA product code NAC: Dressing, Wound, Hydrophilic
NAC is the FDA product code for dressing, wound, hydrophilic. It is a Class I device, regulated under 21 CFR 878.4018 and reviewed by the General and Plastic Surgery panel. FDA has cleared 4 510(k) submissions under NAC, from 4 different applicants. The average 510(k) review took 96 days (median 84). FDA has posted 9 recalls for NAC devices, 7 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Dressing, Wound, Hydrophilic |
| 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 NAC clearance
Top NAC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Scivolutions, Inc. | 1 | 2008-12-01 |
| Avitar, Inc. | 1 | 1993-05-12 |
| Dow B. Hickam, Inc. | 1 | 1991-12-04 |
| Adri/Technam | 1 | 1991-12-04 |
Most recent NAC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K082208 | Scivolutions, Inc. | DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER | 2008-12-01 | 118 |
| K925841 | Avitar, Inc. | HYDRASORB JOYCE SPONGE | 1993-05-12 | 175 |
| K914575 | Dow B. Hickam, Inc. | SORBSAN TOPICAL WOUND DRESSING (MODIFIED) | 1991-12-04 | 50 |
| K914779 | Adri/Technam | ALGINATE FIBER | 1991-12-04 | 42 |
Recalls for NAC devices
9 product recalls in 7 recall events; 7 initiated in the last five years and 7 still open. Most recent: 2026-05-18.
| Year | Recalls |
|---|---|
| 2024 | 5 |
| 2025 | 1 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code NAC?
NAC is the FDA product code for dressing, wound, hydrophilic. 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 NAC?
Class I, regulation 21 CFR 878.4018. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NAC?
Across 4 cleared submissions the average was 96 days from receipt to decision (median 84).
Which companies have the most NAC clearances?
Scivolutions, Inc. (1); Avitar, Inc. (1); Dow B. Hickam, Inc. (1); Adri/Technam (1).
Have NAC devices been recalled?
Yes: 9 product recalls across 7 recall events; the most recent began 2026-05-18.
Next steps
- Run an FDA pathway report with predicate devices for product code NAC
- Run a recall and safety report across every NAC manufacturer
- Watch product code NAC 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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