510(k) · Cleared

Cleared

Pneumrx Family of Biopsy Needles and Kits

K052435510(k) TraditionalCleared Nov 3, 200558-day reviewClass II21 CFR 876.1075

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cleared on Nov 3, 2005 as substantially equivalent to K041544 (Urological, Inc., 2004) and 28 other predicates after a 58-day review. Its family tree reaches back 5 generations to 1987. 2 of the 71 devices in its family, counting itself, have a Class I recall.

Decided: Nov 3, 2005
Review: 58 days
Class: Class II
Product code: KNW
Recalls: None
Predicates: 29

Its longest line of descent runs back 5 generations to K871390 (1987). 70 ancestors in all, the oldest K822630 (1982). No later device cites it as a predicate yet. 2 of the 71 devices in this family, counting this one, have a Class I recall.

By dateBy generation

Root · 5 generations backK871390 Bard Biopty Biopsy SystemC.R. Bard, Inc. · 1987
4 generations backK962969 Medical Device Technologies, Inc.UltraMedical Device Technologies, Inc. · 1996
3 generations backK982085 Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic…Medical Device Technologies, Inc. · 1998
2 generations backK982960 Meical Device Technologies, Inc. Tru-Core Disposable Automatic…Medical Device Technologies, Inc. · 1998 · Recalled
1 generation backK990839 Tru-Core I Reusable Biopsy InstrumentMedical Device Technologies, Inc. · 1999
This deviceK052435 Pneumrx Family of Biopsy Needles and KitsPneumrx, Inc. · 2005

Class I recalls in this family

K980196 MD Tech Biopsy Set for Bone and Bone Marrow2 generations back · 1998
K911202 Atraumatic Standard Sprotte Needle2 generations back · 1992

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K871390	Bard Biopty Biopsy System	C.R. Bard, Inc.	1987	—
−4	K962969	Medical Device Technologies, Inc.Ultra	Medical Device Technologies, Inc.	1996	—
−3	K982085	Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic Biopdy…	Medical Device Technologies, Inc.	1998	—
−2	K982960	Meical Device Technologies, Inc. Tru-Core Disposable Automatic Biopsy Instrument	Medical Device Technologies, Inc.	1998	2
−1	K990839	Tru-Core I Reusable Biopsy Instrument	Medical Device Technologies, Inc.	1999	—
0 (this device)	K052435	Pneumrx Family of Biopsy Needles and Kits	Pneumrx, Inc.	2005	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1982	1	0
1985	7	0
1986	1	0
1987	1	0
1988	1	0
1989	3	0
1990	1	0
1991	1	0
1992	3	1
1993	1	0
1994	4	0
1995	1	0
1996	2	0
1997	6	0
1998	13	1
1999	3	0
2000	3	0
2001	4	0
2002	3	0
2003	2	0
2004	2	0
2005	2	0

FIG. 1 — Lineage of K052435, 1987–2005Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new KNW device

#1 K260572 Marrow Marxmanscore 14.5 · 10 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (30)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K041544	Cook Sidearm Core Tissue Biopsy Device Summary page 1 …s and Kits Primary Classification Names: Biopsy Needle and Needle Set Ill. Predicate Devices * Cook® Sidearm Core Tissue Biopsy Device/Set (K041544) * Biopsy Sciences, LLC. Maxi-Cell Biopsy Needles (K021847) * Boston Scientific Corp. Interject Injection Thera…	Urological, Inc.	2004	—
*	K021847	Biopsy Sciences, LLC. Maxi-Cell Biopsy Needles Summary page 1 …le and Needle Set Ill. Predicate Devices * Cook® Sidearm Core Tissue Biopsy Device/Set (K041544) * Biopsy Sciences, LLC. Maxi-Cell Biopsy Needles (K021847) * Boston Scientific Corp. Interject Injection Therapy Needle (K012864) * ISPG, Inc. Chiba Needle (K012358)…	Biopsy Sciences, LLC	2002	—
*	K012864	Interject Injection Therapy Needle, Models 1810, 1811, 1815, 1816, 1820, 1821, 1825… Summary page 1 …ue Biopsy Device/Set (K041544) * Biopsy Sciences, LLC. Maxi-Cell Biopsy Needles (K021847) * Boston Scientific Corp. Interject Injection Therapy Needle (K012864) * ISPG, Inc. Chiba Needle (K012358) * INRAD, Inc. AccuCore Core Biopsy Needle (K981166) * INRAD, Inc.…	Boston Scientific Corp	2001	—
*	K012358	Chiba Needle Summary page 1 …psy Sciences, LLC. Maxi-Cell Biopsy Needles (K021847) * Boston Scientific Corp. Interject Injection Therapy Needle (K012864) * ISPG, Inc. Chiba Needle (K012358) * INRAD, Inc. AccuCore Core Biopsy Needle (K981166) * INRAD, Inc. AccuCore Single Action Core Biopsy Device (K0…	Ispg, Inc.	2001	—
*	K981166	Accucore Core Biopsy Needle Catalog Codes:581014, 581614, 581618, 582018, 582518… Summary page 1 …* Boston Scientific Corp. Interject Injection Therapy Needle (K012864) * ISPG, Inc. Chiba Needle (K012358) * INRAD, Inc. AccuCore Core Biopsy Needle (K981166) * INRAD, Inc. AccuCore Single Action Core Biopsy Device (K000612) * INRAD, Inc. Co-axial Introducer Needle (K98…	Inrad	1998	—
*	K000612	Accucore Single Action Core Biopsy Device Summary page 1 …* ISPG, Inc. Chiba Needle (K012358) * INRAD, Inc. AccuCore Core Biopsy Needle (K981166) * INRAD, Inc. AccuCore Single Action Core Biopsy Device (K000612) * INRAD, Inc. Co-axial Introducer Needle (K981721) * Ethicon Endo-Surgery, Inc. Mammotome Biopsy System (K992813…	Inrad	2000	—
*	K981721	C0-Axial Introducer Needle Summary page 1 …, Inc. AccuCore Core Biopsy Needle (K981166) * INRAD, Inc. AccuCore Single Action Core Biopsy Device (K000612) * INRAD, Inc. Co-axial Introducer Needle (K981721) * Ethicon Endo-Surgery, Inc. Mammotome Biopsy System (K992813) * Medical Device Technologies, Inc. Tru-CoreTM I…	Inrad	1998	—
*	K992813	11 Gauge Probe, Stereotactic, 14 Gauge Probe, Stereotactic,14 Gauge Probe, Ultrasound… Summary page 1 …uCore Single Action Core Biopsy Device (K000612) * INRAD, Inc. Co-axial Introducer Needle (K981721) * Ethicon Endo-Surgery, Inc. Mammotome Biopsy System (K992813) * Medical Device Technologies, Inc. Tru-CoreTM I Reusable Biopsy Instrument (K990839) * Medical Tech…	Ethicon Endo-Surgery, Inc.	1999	—
*	K990839	Tru-Core I Reusable Biopsy Instrument Summary page 1 …) * Ethicon Endo-Surgery, Inc. Mammotome Biopsy System (K992813) * Medical Device Technologies, Inc. Tru-CoreTM I Reusable Biopsy Instrument (K990839) * Medical Tech. Introducer Needle for Biopsy Needles (K981889) * United States Endoscopy Group, Inc. Coaxial Nee…	Medical Device Technologies, Inc.	1999	—
*	K981889	Worldwide Medical Technologies Introducer Needle Summary page 1 …) * Medical Device Technologies, Inc. Tru-CoreTM I Reusable Biopsy Instrument (K990839) * Medical Tech. Introducer Needle for Biopsy Needles (K981889) * United States Endoscopy Group, Inc. Coaxial Needle (K971842) * Parallax Medical Clearview Plus Bone and Verteb…	Worldwide Medical Technologies, LLC	1998	—
*	K971842	Coaxial Needle Summary page 1 …psy Instrument (K990839) * Medical Tech. Introducer Needle for Biopsy Needles (K981889) * United States Endoscopy Group, Inc. Coaxial Needle (K971842) * Parallax Medical Clearview Plus Bone and Vertebral Body Biopsy Needles (K022169) * Stryker Bone an…	United States Endoscopy Group, Inc.	1997	1
*	K022169	Clearview Plus Bone and Vertebral Body Biopsy Needles Summary page 1 …889) * United States Endoscopy Group, Inc. Coaxial Needle (K971842) * Parallax Medical Clearview Plus Bone and Vertebral Body Biopsy Needles (K022169) * Stryker Bone and Vertebral Body Biopsy Kit and Stryker Capture Bone and Vertebral Body Biopsy Kit (K032943…	Parallax Medical, Inc.	2002	—
*	K032943	Stryker Vertebral Body and Bone Biopsy Kits, Stryker Capture Body and Bone Biospsy Kits Summary page 1 …tebral Body Biopsy Needles (K022169) * Stryker Bone and Vertebral Body Biopsy Kit and Stryker Capture Bone and Vertebral Body Biopsy Kit (K032943) * MD Technologies lnterV Brand SnareLok Bone Marrow Biopsy Needle (K043523) * Orthovita, Inc. Imbibe Bone Marrow…	Stryker Corp.	2003	—
*	K043523	Interv Brand Snarelok Bone Marrow Biopsy Needle Summary page 1 …l Body Biopsy Kit and Stryker Capture Bone and Vertebral Body Biopsy Kit (K032943) * MD Technologies lnterV Brand SnareLok Bone Marrow Biopsy Needle (K043523) * Orthovita, Inc. Imbibe Bone Marrow Aspiration Needle (K050795) * Medical Device Technologies, Inc. Chiba, Spin…	Medical Device Technologies, Inc.	2005	—
*	K050795	Imbibe Bone Marrow Aspiration Needle Summary page 1 …Biopsy Kit (K032943) * MD Technologies lnterV Brand SnareLok Bone Marrow Biopsy Needle (K043523) * Orthovita, Inc. Imbibe Bone Marrow Aspiration Needle (K050795) * Medical Device Technologies, Inc. Chiba, Spinal, Automatic Cutting, General Purpose Introducer, Techna-Cut…	Orthovita, Inc.	2005	—
*	K980211	Mri Chiba,Spinal,Breast Localization,Automatic Cutting Needles	Manan Medical Products, Inc.	1998	—
*	K980122	Manan Soft Tissue Biopsy Needles Summary page 1 …, Techna-Cut Biopsy, Super-Core Biopsy, Breast Localization and Simon Breast Localization Needles (K98021 I) * MD MananTM Soft Tissue Biopsy Needles (K980122) * Daum Corp. Aspiration-Biopsy Needle (K974575) * Promex/ US Biopsy Prostate Seeding Needle (K973 184) *…	Medical Device Technologies, Inc.	1998	—
*	K974575	Daum Aspirationbiopsy Needle Summary page 1 …ion and Simon Breast Localization Needles (K98021 I) * MD MananTM Soft Tissue Biopsy Needles (K980122) * Daum Corp. Aspiration-Biopsy Needle (K974575) * Promex/ US Biopsy Prostate Seeding Needle (K973 184) * Klein-Baker Med. Neo-Care Lumbar Puncture Kit (K970997)…	Daum Corp.	1998	—
*	K973184	Prostate Seeding Needle Summary page 1 …I) * MD MananTM Soft Tissue Biopsy Needles (K980122) * Daum Corp. Aspiration-Biopsy Needle (K974575) * Promex/ US Biopsy Prostate Seeding Needle (K973 184) * Klein-Baker Med. Neo-Care Lumbar Puncture Kit (K970997) Premarket Notification, 510(k) Submission for:…	Promex, Inc.	1997	—
*	K970997	Neo-Care Lumber Puncture Kit Summary page 1 …* Daum Corp. Aspiration-Biopsy Needle (K974575) * Promex/ US Biopsy Prostate Seeding Needle (K973 184) * Klein-Baker Med. Neo-Care Lumbar Puncture Kit (K970997) Premarket Notification, 510(k) Submission for: Attachment 32- Page I PneumRx Family of Biopsy N…	Klein-Baker Medical, Inc.	1997	—
*	K982269	Clear Hub Spinal Needle 14GA, 16GA, 17GA, 18GA, 20GA, 21GA, 22GA, 25GA, 26GA and 27GA Summary page 2 …Family of Biopsy Needles and Kits Page revised - 24 October 2005 * Allegiance Healthcare Clear Hub Spinal Needle (K982269) * SIMS Spinal Anesthesia Needle (K983858) * Ferguson Medical SmartGuide (K963894) * US Biopsy A…	Allegiance Healthcare Corp.	1998	—
*	K983858	Spinal Anesthesia Needles and Introducer Needles Summary page 2 …Page revised - 24 October 2005 * Allegiance Healthcare Clear Hub Spinal Needle (K982269) * SIMS Spinal Anesthesia Needle (K983858) * Ferguson Medical SmartGuide (K963894) * US Biopsy Automated Core Biopsy Device (K994272 and K01 1270)…	Sims Portex, Inc.	1999	—
*	K963894	Smartguide Summary page 2 …2 === * Allegiance Healthcare Clear Hub Spinal Needle (K982269) * SIMS Spinal Anesthesia Needle (K983858) * Ferguson Medical SmartGuide (K963894) * US Biopsy Automated Core Biopsy Device (K994272 and K01 1270) * INRAD, Inc. Aspiration Biopsy Needle (K…	Ferguson Medical	1997	—
*	K994272	Automated Core Biopsy Device Summary page 2 …le (K982269) * SIMS Spinal Anesthesia Needle (K983858) * Ferguson Medical SmartGuide (K963894) * US Biopsy Automated Core Biopsy Device (K994272 and K01 1270) * INRAD, Inc. Aspiration Biopsy Needle (K number unknown) * Cook Chiba Aspiration Biopsy Need…	Promex, Inc.	2000	—
*	K011270	Automated Core Biopsy Device Summary page 2 …* SIMS Spinal Anesthesia Needle (K983858) * Ferguson Medical SmartGuide (K963894) * US Biopsy Automated Core Biopsy Device (K994272 and K01 1270) * INRAD, Inc. Aspiration Biopsy Needle (K number unknown) * Cook Chiba Aspiration Biopsy Needles (K851957)…	Promex, Inc.	2001	—
*	K851957	Chiba Needle Summary page 2 …tomated Core Biopsy Device (K994272 and K01 1270) * INRAD, Inc. Aspiration Biopsy Needle (K number unknown) * Cook Chiba Aspiration Biopsy Needles (K851957) * MD MananTM Co-Axial Introducer Needles (K980004) * MananTM MD Super-Core Biopsy Needle (K974814)…	Wilson-Cook Medical, Inc.	1985	—
*	K980004	Manan General Purpose Introducer Needle Summary page 2 …INRAD, Inc. Aspiration Biopsy Needle (K number unknown) * Cook Chiba Aspiration Biopsy Needles (K851957) * MD MananTM Co-Axial Introducer Needles (K980004) * MananTM MD Super-Core Biopsy Needle (K974814) * MD MananTM Techna-Cut Biopsy Needle (K974766) IV.…	Medical Device Technologies, Inc.	1998	—
*	K974814	Manan (TM) Super-Core Biopsy Needles Summary page 2 …* Cook Chiba Aspiration Biopsy Needles (K851957) * MD MananTM Co-Axial Introducer Needles (K980004) * MananTM MD Super-Core Biopsy Needle (K974814) * MD MananTM Techna-Cut Biopsy Needle (K974766) IV. Product Description The PneumRx Family of Biopsy N…	Medical Device Technologies, Inc.	1998	1
*	K974766	Manan Techna-Cut Aspiration Needle Summary page 2 …* MD MananTM Co-Axial Introducer Needles (K980004) * MananTM MD Super-Core Biopsy Needle (K974814) * MD MananTM Techna-Cut Biopsy Needle (K974766) IV. Product Description The PneumRx Family of Biopsy Needles and Kits are comprised of the following main…	Medical Device Technologies, Inc.	1998	—
*	—	INRAD, Inc. Aspiration Biopsy Needle Named without a submission number			—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (2 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

K980196MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 13 Class I recalls
K911202Atraumatic Standard Sprotte NeedlePajunk GmbH · 1992 · 2 generations back · ◆ in the 1992 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
7 of the 70 ancestors have a recall of any class; 2 have a Class I recall.

How does its category compare?

All KNW devices

KNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNW

12in 2025

2007high 12 (2025) · low 3 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNW

178in 2025

2007high 203 (2022) · low 35 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KNW

1in 2024

2007high 7 (2008) · low 0 (2015)2026

Class I (4 since 2007) Class II/III not classified

Adverse event reports per year · KNW

1,667in 2025

2007high 5,120 (2020) · low 67 (2011)2025

MAUDE reports naming product code KNW, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	6	94	1	766
2008	4	53	7	363
2009	6	35	3	351
2010	3	57	2	162
2011	10	64	5	67
2012	7	94	1	93
2013	3	100	1 (1)	98
2014	8	95	3	193
2015	10	106	0	591
2016	9	127	5	297
2017	8	90	1	760
2018	7	71	0	1,012
2019	5	94	4	4,195
2020	8	92	0	5,120
2021	9	54	3	1,020
2022	8	203	3	535
2023	7	164	2	931
2024	5	114	1	1,283
2025	12	178	0	1,667
2026	7	29	4 (3)	—

What is it indicated for?

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…

Read the full statement (448 words)

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052435 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052435: Pneumrx Family of Biopsy Needles and Kits.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052435

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026