# K052435: Pneumrx Family of Biopsy Needles and Kits - Pathway: 510(k) (Traditional) - Applicant: Pneumrx, Inc. - Decided: Nov 3, 2005 after 58 days - Product code: KNW (Instrument, Biopsy) - Device class: 2 - Regulation: 21 CFR 876.1075 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 5 generations back to K871390 (1987). 70 ancestors in all. No later device cites it as a predicate yet. 2 of 71 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K041544: Cook Sidearm Core Tissue Biopsy Device, Urological, Inc. (2004) Summary page 1. - K021847: Biopsy Sciences, LLC. Maxi-Cell Biopsy Needles, Biopsy Sciences, LLC (2002) Summary page 1. - K012864: Interject Injection Therapy Needle, Models 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836, Boston Scientific Corp (2001) Summary page 1. - K012358: Chiba Needle, Ispg, Inc. (2001) Summary page 1. - K981166: Accucore Core Biopsy Needle Catalog Codes:581014, 581614, 581618, 582018, 582518, 581620, 582020, 581214, Inrad (1998) Summary page 1. - K000612: Accucore Single Action Core Biopsy Device, Inrad (2000) Summary page 1. - K981721: C0-Axial Introducer Needle, Inrad (1998) Summary page 1. - K992813: 11 Gauge Probe, Stereotactic, 14 Gauge Probe, Stereotactic,14 Gauge Probe, Ultrasound, Housing Stereotactic,Housing, Ult, Ethicon Endo-Surgery, Inc. (1999) Summary page 1. - K990839: Tru-Core I Reusable Biopsy Instrument, Medical Device Technologies, Inc. (1999) Summary page 1. - K981889: Worldwide Medical Technologies Introducer Needle, Worldwide Medical Technologies, LLC (1998) Summary page 1. - K971842: Coaxial Needle, United States Endoscopy Group, Inc. (1997) Summary page 1. - K022169: Clearview Plus Bone and Vertebral Body Biopsy Needles, Parallax Medical, Inc. (2002) Summary page 1. - K032943: Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body and Bone Biospsy Kits, Stryker Corp. (2003) Summary page 1. - K043523: Interv Brand Snarelok Bone Marrow Biopsy Needle, Medical Device Technologies, Inc. (2005) Summary page 1. - K050795: Imbibe Bone Marrow Aspiration Needle, Orthovita, Inc. (2005) Summary page 1. - K980211: Mri Chiba,Spinal,Breast Localization,Automatic Cutting Needles, Manan Medical Products, Inc. (1998) - K980122: Manan Soft Tissue Biopsy Needles, Medical Device Technologies, Inc. (1998) Summary page 1. - K974575: Daum Aspirationbiopsy Needle, Daum Corp. (1998) Summary page 1. - K973184: Prostate Seeding Needle, Promex, Inc. (1997) Summary page 1. - K970997: Neo-Care Lumber Puncture Kit, Klein-Baker Medical, Inc. (1997) Summary page 1. - K982269: Clear Hub Spinal Needle 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA and 27GA, Allegiance Healthcare Corp. (1998) Summary page 2. - K983858: Spinal Anesthesia Needles and Introducer Needles, Sims Portex, Inc. (1999) Summary page 2. - K963894: Smartguide, Ferguson Medical (1997) Summary page 2. - K994272: Automated Core Biopsy Device, Promex, Inc. (2000) Summary page 2. - K011270: Automated Core Biopsy Device, Promex, Inc. (2001) Summary page 2. - K851957: Chiba Needle, Wilson-Cook Medical, Inc. (1985) Summary page 2. - K980004: Manan General Purpose Introducer Needle, Medical Device Technologies, Inc. (1998) Summary page 2. - K974814: Manan (TM) Super-Core Biopsy Needles, Medical Device Technologies, Inc. (1998) Summary page 2. - K974766: Manan Techna-Cut Aspiration Needle, Medical Device Technologies, Inc. (1998) Summary page 2. - (no number) INRAD, Inc. Aspiration Biopsy Needle: named in the summary without a submission number ## Indications for use The PneumRx Family of Biopsy Needles and Kits is intended for use in obtaining bone, vertebral body, and bone marrow biopsy specimens, and single and multiple tissue biopsy specimens of tissues or lesions, partial or complete removal of imaged abnormalities, in soft tissues, for applying radionuclide sources into the body, and for aspirating, draining, or injecting various fluids or contents (e.g., sclerosing agents, vasoconstrictors, anesthetics, ethanol, saline, heparin, and other historically used, approved, and/or generally accepted medical fluids in accordance with the judgment and training of the medical practitioner). The PneumRx Family of Biopsy Needles and Kits is indicated for use in obtaining bone, vertebral body, and/or bone marrow biopsy using coring, cutting or aspiration, as well as providing and maintaining surgical site access with coaxial biopsy needle kits. They are also indicated for use in percutaneous, open surgical, fine needle, tissue core, coaxial, and aspiration biopsy/ tissue sampling of soft tissues for: * Microscopic, histologic, diagnostic, evaluation - Fluoroscopic, ultrasound (US), computed tomography (CT)/x-ray, mammographic imaging, MRI (magnetic resonance imaging), and/or direct visualization - Guiding biopsy needles to the target lesion * Avoiding punctures in non-penetrable anatomic obstacles (e.g., bone, spine) or vital structures (e.g., blood vessels, nerves) * Obtaining multiple biopsy, core biopsy, and aspiration biopsy tissue samples with partial or complete removal of the imaged abnormality - Aspirating, draining, or injecting various fluids or contents in soft tissues, including introduction of sclerosing agents or vasoconstrictors to control actual or potential bleeding * Pericardiocentesis, transhepatic cholorangiography, and other applications requiring injection or aspiration of fluids • Lumbar puncture, spinal fluid sampling, local anesthetic injection to provide regional nerve block/anesthesia, and amniocentesis * Manual application of a radionuclide source into or on the body for radiation therapy * Including, but not limited to, the following anatomical locations and lesions: Pleural cavity Lung Lymph nodes > Thyroid > Adrenals Soft tissue organs of the abdomen and thorax > Abdominal cavity/ abdominal soft tissue masses > Kidney Liver Spleen Pancreas Prostate Tumors Cysts Fluid spaces > Soft tissue lesions or tissue spaces Breast: * The PneumRx Family of Biopsy Needles and Kits is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality; * The extent of a histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures. Source page: https://510kreport.com/device/K052435 Methodology: https://510kreport.com/methodology