FDA product code NEC: Bandage, Liquid, Skin Protectant
NEC is the FDA product code for bandage, liquid, skin protectant. It is a Class I device, regulated under 21 CFR 880.5090 and reviewed by the General and Plastic Surgery panel. FDA has cleared 3 510(k) submissions under NEC, from 2 different applicants. The average 510(k) review took 105 days (median 77). FDA has posted 6 recalls for NEC devices.
Classification
| Field | Value |
|---|---|
| Device name | Bandage, Liquid, Skin Protectant |
| Device class | Class I |
| Regulation | 21 CFR 880.5090 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every NEC clearance
Top NEC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Aplicare, Inc. | 2 | 1986-07-11 |
| Medlogic Global Corp. | 1 | 1997-12-17 |
Most recent NEC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K972081 | Medlogic Global Corp. | SUPERSKIN | 1997-12-17 | 197 |
| K861557 | Aplicare, Inc. | APLICARE SKIN PROTECTANT PREP PAD | 1986-07-11 | 77 |
| K861558 | Aplicare, Inc. | APLICARE SKIN PROTECTANT SWABSTICK | 1986-06-04 | 40 |
Recalls for NEC devices
6 product recalls in 4 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2018-08-30.
| Year | Recalls |
|---|---|
| 2018 | 1 |
Frequently asked questions
What is FDA product code NEC?
NEC is the FDA product code for bandage, liquid, skin protectant. It is a Class I device, regulated under 21 CFR 880.5090 and reviewed by the General and Plastic Surgery panel.
What device class is NEC?
Class I, regulation 21 CFR 880.5090. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code NEC?
Across 3 cleared submissions the average was 105 days from receipt to decision (median 77).
Which companies have the most NEC clearances?
Aplicare, Inc. (2); Medlogic Global Corp. (1).
Have NEC devices been recalled?
Yes: 6 product recalls across 4 recall events; the most recent began 2018-08-30.
Next steps
- Run an FDA pathway report with predicate devices for product code NEC
- Run a recall and safety report across every NEC manufacturer
- Watch product code NEC 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