# Inrad

- Location (FDA's records): Kentwood, MI
- FDA decisions: 15 (1998–2025): 15 510(k) clearances
- Names in FDA's records: Inrad (11); Inrad, Inc. (4)
- Product codes: KNW (8), NEU (4), GDW (2), LHI (1)
- 510(k) review time since 2016: median 268 days, against 178 for FDA's reviews in the same codes and years (1 of 3 faster)
- Predicates its devices cite: 12 (4 its own); citations of its devices by later devices: 10 (4 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Manan Medical Products, Inc.: 3 (https://510kreport.com/company/manan-medical-products)
- Dip, Inc.: 1 (https://510kreport.com/company/dip)
- Biopsys Medical, Inc.: 1 (https://510kreport.com/company/biopsys-medical)
- Vibronics: 1 (https://510kreport.com/company/vibronics)
- Promex, Inc.: 1 (https://510kreport.com/company/promex)
- Bauer Medical, Inc.: 1 (https://510kreport.com/company/bauer-medical)

## Firms that cite its devices most
- Pneumrx, Inc.: 3 (https://510kreport.com/company/pneumrx)
- Mri Devices Corp.: 1 (https://510kreport.com/company/mri-devices)
- Hakko Medical Co., Ltd.: 1 (https://510kreport.com/company/hakko-medical)
- C.R. Bard, Inc.: 1 (https://510kreport.com/company/cr-bard)

## Its most-cited devices
- K981166: Accucore Core Biopsy Needle Catalog Codes:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214 (1998), cited by 2
- K993785: Ultraclip Tissue Marker (2000), cited by 2
- K090611: Revolution Full Core Biopsy (2009), cited by 2
- K000612: Accucore Single Action Core Biopsy Device (2000), cited by 1
- K063238: Ultraclip II Wing and Ultraclip II Coil (2007), cited by 1
- K183503: EasyMark Tissue Marker (2019), cited by 1

## Recent decisions
- K243886: ExpressCore Biopsy Device (Apr 29, 2025)
- K240429: Trilogy Tissue Marker (Nov 7, 2024)
- K183503: EasyMark Tissue Marker (Oct 17, 2019)
- K112945: Elitecore Full Core Biopsy Device 18GAX10CM, 18GAX15CM, 18GAX20, with/Hilitier 18GAX10CM , W/Hiliter 18GAX15CM (Nov 3, 2011)
- K093399: Precisecore 10 MM Biopsy Device- 14GA X 5 CM Model 670514, 671014, 670518 671018, 670520 (Nov 19, 2009)
- K093256: Selectcore Variable Throw Biopsy Device Model 991014, 991514, 991018, 991518, 992018 (Nov 17, 2009)
- K090611: Revolution Full Core Biopsy (Jun 4, 2009)
- K063238: Ultraclip II Wing and Ultraclip II Coil (Jan 30, 2007)

Source page: https://510kreport.com/company/inrad