FDA product code NEU: Marker, Radiographic, Implantable
NEU is the FDA product code for marker, radiographic, implantable. It is a Class II device, regulated under 21 CFR 878.4300 and reviewed by the General and Plastic Surgery panel. FDA has cleared 110 510(k) submissions under NEU, 22 in the last five years, from 48 different applicants. The average 510(k) review took 121 days (median 92); 131 days on average over the last three years. FDA has posted 14 recalls for NEU devices, 10 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Marker, Radiographic, Implantable |
| Device class | Class II |
| Regulation | 21 CFR 878.4300 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for NEU
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 102 |
| 2018 | 8 | 80 |
| 2019 | 5 | 148 |
| 2020 | 3 | 206 |
| 2021 | 3 | 101 |
| 2022 | 2 | 246 |
| 2023 | 4 | 188 |
| 2024 | 10 | 242 |
| 2025 | 5 | 92 |
| 2026 | 1 | 59 |
Compare with all 510(k) review times · Search every NEU clearance
Top NEU applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Devicor Medical Products, Inc. | 9 | 2026-01-23 |
| Senorx, Inc. | 7 | 2013-06-27 |
| Carbon Medical Technologies, Inc. | 6 | 2025-07-23 |
| Somatex Medical Technologies GmbH | 6 | 2021-02-18 |
| Biopsy Sciences, LLC | 6 | 2013-03-29 |
43 more applicants have NEU clearances. See the full list in Caduvo.
Most recent NEU clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K253761 | Devicor Medical Products, Inc. | HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) | 2026-01-23 | 59 |
| K253888 | Stryker Endoscopy | MOLLI 2 System | 2025-12-31 | 27 |
| K252892 | Merit Medical Systems, Inc. | SCOUT MD Surgical Guidance System | 2025-12-19 | 99 |
| K251989 | Breast-Med, Inc. | VizMark Preloaded Tissue Marker Device (VM-0001) | 2025-12-12 | 168 |
| K251748 | Carbon Medical Technologies, Inc. | MammoSTAR Biopsy Site Identifier | 2025-07-23 | 47 |
Recalls for NEU devices
14 product recalls in 12 recall events; 10 initiated in the last five years and 8 still open. Most recent: 2026-04-24.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2022 | 3 |
| 2024 | 3 |
| 2025 | 2 |
| 2026 | 2 |
HCPCS codes with matching descriptors
Text match between the FDA device name and CMS descriptors, not an official crosswalk:
- A4648 — Tissue marker, implantable, any type, each
Frequently asked questions
What is FDA product code NEU?
NEU is the FDA product code for marker, radiographic, implantable. It is a Class II device, regulated under 21 CFR 878.4300 and reviewed by the General and Plastic Surgery panel.
What device class is NEU?
Class II, regulation 21 CFR 878.4300. Typical premarket route: 510(k).
How long does a 510(k) take for product code NEU?
Across 110 cleared submissions the average was 121 days from receipt to decision (median 92).
Which companies have the most NEU clearances?
Devicor Medical Products, Inc. (9); Senorx, Inc. (7); Carbon Medical Technologies, Inc. (6); Somatex Medical Technologies GmbH (6); Biopsy Sciences, LLC (6).
Have NEU devices been recalled?
Yes: 14 product recalls across 12 recall events; the most recent began 2026-04-24.
Next steps
- Run an FDA pathway report with predicate devices for product code NEU
- Run a recall and safety report across every NEU manufacturer
- Watch product code NEU 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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