FDA product code NKA: System, Documentation, Breast Lesion
NKA is the FDA product code for system, documentation, breast lesion. It is a Class II device, regulated under 21 CFR 884.2990 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 3 510(k) submissions under NKA, from 2 different applicants. The average 510(k) review took 232 days (median 197). 1 De Novo request was granted under it.
Definition
A Breast lesion documentation device is a device for recording and documenting palpable breast lesions detected during a clinical breast exam.
Classification
| Field | Value |
|---|---|
| Device name | System, Documentation, Breast Lesion |
| Device class | Class II |
| Regulation | 21 CFR 884.2990 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
510(k) clearances per year for NKA
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 2 | 250 |
Compare with all 510(k) review times · Search every NKA clearance
Top NKA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ue Lifesciences, Inc. | 2 | 2019-07-16 |
| Sure, Inc. | 1 | 2019-06-28 |
Most recent NKA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K190575 | Ue Lifesciences, Inc. | iBreastExam | 2019-07-16 | 132 |
| K181672 | Sure, Inc. | SureTouch Mobile Pressure Mapping System | 2019-06-28 | 368 |
| K142926 | Ue Lifesciences, Inc. | iBreastExam | 2015-04-23 | 197 |
Recalls for NKA devices
openFDA lists no recalls for product code NKA.
Frequently asked questions
What is FDA product code NKA?
NKA is the FDA product code for system, documentation, breast lesion. It is a Class II device, regulated under 21 CFR 884.2990 and reviewed by the Obstetrics and Gynecology panel.
What device class is NKA?
Class II, regulation 21 CFR 884.2990. Typical premarket route: 510(k).
How long does a 510(k) take for product code NKA?
Across 3 cleared submissions the average was 232 days from receipt to decision (median 197).
Which companies have the most NKA clearances?
Ue Lifesciences, Inc. (2); Sure, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code NKA
- Run a recall and safety report across every NKA manufacturer
- Watch product code NKA 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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