FDA product code MAC: Decontamination Kit
MAC is the FDA product code for decontamination kit. It is a Class I device, regulated under 21 CFR 878.4014 and reviewed by the General Hospital panel. FDA has cleared 2 510(k) submissions under MAC. The average 510(k) review took 68 days (median 68). FDA has posted 1 recall for MAC devices, 1 initiated in the last five years.
Definition
This product code has been established in accordance with the May 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Classification
| Field | Value |
|---|---|
| Device name | Decontamination Kit |
| Device class | Class I |
| Regulation | 21 CFR 878.4014 |
| Review panel | HO — General Hospital |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MAC clearance
Top MAC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dept. of the Army | 2 | 2003-03-25 |
Most recent MAC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K023969 | Dept. of the Army | REACTIVE SKIN DECONTAMINATION LOTION | 2003-03-25 | 116 |
| K894455 | Dept. of the Army | DECONTAMINATING KIT, SKIN: M291 | 1989-08-15 | 21 |
Recalls for MAC devices
1 product recalls in 1 recall events; 1 initiated in the last five years and 0 still open. Most recent: 2022-11-24.
| Year | Recalls |
|---|---|
| 2022 | 1 |
Frequently asked questions
What is FDA product code MAC?
MAC is the FDA product code for decontamination kit. It is a Class I device, regulated under 21 CFR 878.4014 and reviewed by the General Hospital panel.
What device class is MAC?
Class I, regulation 21 CFR 878.4014. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MAC?
Across 2 cleared submissions the average was 68 days from receipt to decision (median 68).
Which companies have the most MAC clearances?
Dept. of the Army (2).
Have MAC devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2022-11-24.
Next steps
- Run an FDA pathway report with predicate devices for product code MAC
- Run a recall and safety report across every MAC manufacturer
- Watch product code MAC 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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