Inrad: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Inrad” (first 1998, latest 2025), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 74 days. Since 2017 the median was 268 days, against 131 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 1 | 304 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 1 | 268 |
| 2025 | 1 | 132 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Inrad took a median 268 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 131 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KNW | Instrument, Biopsy | 8 | 8 |
| NEU | Marker, Radiographic, Implantable | 4 | 4 |
| GDW | Staple, Implantable | 2 | 2 |
| LHI | Set, I.V. Fluid Transfer | 1 | 1 |
Review panels
Most recent Inrad 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243886 | ExpressCore Biopsy Device | KNW | 2025-04-29 | 132 |
| K240429 | Trilogy Tissue Marker | NEU | 2024-11-07 | 268 |
| K183503 | EasyMark Tissue Marker | NEU | 2019-10-17 | 304 |
| K112945 | ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM | KNW | 2011-11-03 | 30 |
| K093399 | PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520 | KNW | 2009-11-19 | 17 |
| K093256 | SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018 | KNW | 2009-11-17 | 29 |
| K090611 | REVOLUTION FULL CORE BIOPSY | KNW | 2009-06-04 | 90 |
| K063238 | ULTRACLIP II WING AND ULTRACLIP II COIL | NEU | 2007-01-30 | 96 |
| K042341 | ULTRACLIP II US | NEU | 2004-09-20 | 21 |
| K041201 | ULTRACLIP II MR | GDW | 2004-06-03 | 27 |
5 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2010-12-20.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Inrad (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Inrad?
FDA lists 15 510(k) clearances under the applicant name “Inrad” (first 1998, latest 2025), across 4 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Inrad?
The median time from FDA receipt to decision across 510(k)s cleared under the name Inrad is 74 days. Since 2017: 268 days, versus 131 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Inrad?
The most frequent FDA product codes under this applicant name are KNW (Instrument, Biopsy, 8); NEU (Marker, Radiographic, Implantable, 4); GDW (Staple, Implantable, 2).
Next steps
- See all 15 Inrad clearances with predicates and recalls
- Run predicate analysis for product code KNW, Inrad's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.