FDA product code NAD: Dressing, Wound, Occlusive
NAD is the FDA product code for dressing, wound, occlusive. It is a Class I device, regulated under 21 CFR 878.4020 and reviewed by the General and Plastic Surgery panel. FDA has cleared 108 510(k) submissions under NAD, 1 in the last five years, from 77 different applicants. The average 510(k) review took 91 days (median 72); 255 days on average over the last three years. FDA has posted 19 recalls for NAD devices, 3 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Dressing, Wound, Occlusive |
| Device class | Class I |
| Regulation | 21 CFR 878.4020 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
510(k) clearances per year for NAD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2026 | 1 | 255 |
Compare with all 510(k) review times · Search every NAD clearance
Top NAD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Smith & Nephew, Inc. | 5 | 1987-09-16 |
| Chesebrough-Pond'S U.S.A. Co. | 5 | 1985-07-05 |
| Fraass Survival Systems, Inc. | 4 | 1991-08-02 |
| Convatec, A Division of E.R. Squibb & Sons | 4 | 1989-05-11 |
| The Bfgoodrich Co. | 4 | 1988-04-13 |
72 more applicants have NAD clearances. See the full list in Caduvo.
Most recent NAD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K254246 | Zhejiang Longterm Medical Technology Co., Ltd. | LT Antibacterial Foam with Silver Dressing | 2026-09-10 | 255 |
| K102403 | Sam Medical Products | SAM CHEST SEAL WITH VAVLE; SAM CHEST SEAL | 2011-03-03 | 191 |
| K091133 | Aplion Medical,Llc | APLION TOPICAL CARE SYSTEM | 2009-05-20 | 30 |
| K072560 | Teikoku Pharma USA, Inc. | ENVELA (HYDROHESIVE OCCLUSIVE DRESSING) | 2008-06-17 | 280 |
| K080524 | Tri-State Hospital Supply Corp. | CENTURION SORBAVIEW OTC | 2008-04-23 | 57 |
Recalls for NAD devices
19 product recalls in 10 recall events; 3 initiated in the last five years and 4 still open. Most recent: 2025-08-29.
| Year | Recalls |
|---|---|
| 2017 | 3 |
| 2018 | 6 |
| 2021 | 2 |
| 2022 | 1 |
| 2025 | 2 |
Frequently asked questions
What is FDA product code NAD?
NAD is the FDA product code for dressing, wound, occlusive. It is a Class I device, regulated under 21 CFR 878.4020 and reviewed by the General and Plastic Surgery panel.
What device class is NAD?
Class I, regulation 21 CFR 878.4020. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NAD?
Across 108 cleared submissions the average was 91 days from receipt to decision (median 72).
Which companies have the most NAD clearances?
Smith & Nephew, Inc. (5); Chesebrough-Pond'S U.S.A. Co. (5); Fraass Survival Systems, Inc. (4); Convatec, A Division of E.R. Squibb & Sons (4); The Bfgoodrich Co. (4).
Have NAD devices been recalled?
Yes: 19 product recalls across 10 recall events; the most recent began 2025-08-29.
Next steps
- Run an FDA pathway report with predicate devices for product code NAD
- Run a recall and safety report across every NAD manufacturer
- Watch product code NAD 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 General and Plastic Surgery product codes · FDA product code lookup · 510(k) database search · 510(k) review times