510(k) · Cleared
ClearedMöller Medical Biopsy Needles and Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Moller Medical GmbH · KNW Instrument, Biopsy
Cleared on Jun 19, 2017 as substantially equivalent to K980226 (Medical Device Technologies, Inc., 1998) and 8 other predicates after a 276-day review. Its family tree reaches back 3 generations to 1989. 1 of the 35 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Jun 19, 2017
- Review
- 276 days
- Class
- Class II
- Product code
- KNW
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 3 generations to K890925 (1989). 33 ancestors in all, the oldest K851831 (1985). 1 later device descends from it, 1 citing it directly. 1 of the 35 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK890925 Manan Bone Marrow Biopsy NeedleManan Medical Products, Inc. · 1989 · Recalled
- 2 generations backK961959 MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1996
- 1 generation backK980196 MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1998 · Recalled (Class I)
- This deviceK162588 Möller Medical Biopsy Needles and SystemsMoller Medical GmbH · 2017
- Descendant · cites it directly · 0 of its ownK242128 Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy…Xaga Surgical · 2025
Class I recalls in this family
- K980196 MD Tech Biopsy Set for Bone and Bone Marrowdirect predicate · 1998
Most influential descendants
Showing 1 of 1 · See all- K242128Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall…Xaga Surgical · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K890925 | Manan Bone Marrow Biopsy Needle | Manan Medical Products, Inc. | 1989 | 7 |
| −2 | K961959 | MD Tech Biopsy Set for Bone and Bone Marrow | Medical Device Technologies, Inc. | 1996 | — |
| −1 | K980196 | MD Tech Biopsy Set for Bone and Bone Marrow | Medical Device Technologies, Inc. | 1998 | Class I |
| 0 (this device) | K162588 | Möller Medical Biopsy Needles and Systems | Moller Medical GmbH | 2017 | — |
| +1 | K242128 | Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and… | Xaga Surgical | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 6 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 4 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
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.
1 device in this family has 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
What was it cleared against? (10)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K980226 | Manan Pro-Mag Automatic Biopsy SystemSummary page 6…Class II (RBG-xxxx) Needles, Pro-Mag Ultra Automatic Biopsy Instrument 510(k) No.: K980226 Bone Marrow Biopsy Bone Marrow Aspiration Needles; Bone KNW System Marrow Biopsy Trays… | 1998 |
| * | K980196 | MD Tech Biopsy Set for Bone and Bone MarrowSummary page 6…; Pediatric Bone Marrow Access Needles; (BOY-1080) T-Lok Bone Marrow Needles 510(k) No.: K980196 Fine Needle Biopsy Fine Needle Aspiration (FNA) Biopsy KNW (FNB-xxxx) Needles Chiba; Fran… | 1998 |
| * | K980122 | Manan Soft Tissue Biopsy NeedlesSummary page 6…Cut; Spinal; Trocar; Turner; Westcott Soft Tissue Biopsy Needles 510(k) No.: K980122 Disposable Needles for Biopsy Gun (DNG) DNG-1010 ACN, SACN, Biopsy Needle; KNW… | 1998 |
| * | K974446 | Manan Automatic Cutting NeedleSummary page 6…K980122 Disposable Needles for Biopsy Gun (DNG) DNG-1010 ACN, SACN, Biopsy Needle; KNW 510(k) No.: K974446 Class II DNG-1020; DNG-1030 Pro-Mag Ultra 2.2 Automatic Biopsy KNW… | 1998 |
| * | K111529 | Magnum Core Tissue Biopsy Needle Model MN1820, RP Cutting Needle Model RP-1820, MCN Core…Summary page 6…Class II RP-1820, MCN Core Tissue Biopsy Needle Model MCN 510(k) No.: K111529 2017-05… | 2011 |
| Kept off the family tree | K090487 | FDA’s K090487 is Disposable Angiographic Syringes for Use with Nemoto Angiographic Power, Model… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2009 |
| * | K010735 | SpeedybellSummary page 7….: K904987 Class II Semi-automatic Biopsy Speedybell KNW Gun 510(k) No.: K010735 Class II (SBG-xxxx) Automatic Biopsy Gun Manual-Bone-Marrow-Biopsy-Needles, KNW (AB… | 2001 |
| * | K130616 | Manual-Bone-Marrow-Biopsy-Needles, Semi-Automatic-Biopsy-Needles, Automatic-Biopsy-NeedlesSummary page 7…Semi-Automatic-Biopsy-Needles, Class II ……… Automatic-Biopsy Needles 510(k) No.: K130616 Coaxial Needles Co-Axial Introducer Needle KNW (COX-xxxx) 510(k) No.: K980… | 2014 |
| * | K980004 | Manan General Purpose Introducer NeedleSummary page 7…510(k) No.: K130616 Coaxial Needles Co-Axial Introducer Needle KNW (COX-xxxx) 510(k) No.: K980004 Class II Manual Cut Biopsy 18 Gauge Tru-Cut Biopsy Needle KNW (MBY-xxxx)… | 1998 |
| * | K960509 | 18 Gauge Tru-Cut Biopsy NeedleSummary page 7….: K980004 Class II Manual Cut Biopsy 18 Gauge Tru-Cut Biopsy Needle KNW (MBY-xxxx) 510(k) No.: K960509 Class II 4. The presented Möller Medical products have the same indication and the same technology… | 1996 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242128 | Forsvall biopsy needle system for prostate biopsy (Forsvall biopsy gun and Forsvall… | 2025 | 0 |
Has anything in its family been recalled? (1 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 · Direct predicate · ◆ on the line of descent in FIG. 13 Class I recalls
What does this lineage say?
- The line of descent spans 28 years and passes through 3 companies; a new generation was cleared every 7.3 years on median.
- 5 of the 33 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K242128 (Xaga Surgical, 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K980226.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · KNW
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNW
178in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNW
1in 2024
Class I (4 since 2007) Class II/III not classified
Adverse event reports per year · KNW
1,667in 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 Moller Medical Biopsy Needles and Systems are used to obtain core samples and aspiration from tissue by biopsy. The various wall thicknesses, diameters, tip geometries and cutting techniques of the different hollow needle types and biopsy systems affect the quality of the biopsy specimen. Model BOW-1060 bone marrow biopsy systems are intended for the atraumatic taking of specimens from and inside bones. Application areas of the products are bone…
Read the full statement (452 words)
The Moller Medical Biopsy Needles and Systems are used to obtain core samples and aspiration from tissue by biopsy. The various wall thicknesses, diameters, tip geometries and cutting techniques of the different hollow needle types and biopsy systems affect the quality of the biopsy specimen.
Model BOW-1060 bone marrow biopsy systems are intended for the atraumatic taking of specimens from and inside bones. Application areas of the products are bone respectively bone marrow.
Model BOW-1070 bone marrow aspiration biopsy set is intended for aspiration in the area of the sternum or iliac crest. Application areas of the products are bone respectively bone marrow.
Model BOY-1080 bone biopsy needle set has been designed for atraumatic bone biopsy. Application areas of the products are bone respectively bone marrow.
Model DNG-10XX single-use biopsy needles are exclusively intended for hollow needle biopsies of soft tissue such as liver, kidney, prostate, breast, thyroid, pancreas, spleen, lung and various soft tissue lesions and are combined with biopsy guns.
Model full-sCore® DNG-2020 disposable biopsy needles are intended only for biopsies on soft tissue and tissue from soft, internal organs such as liver, kidney, breast, lung and various soft tissue lesions , and should be used with the Moéller Medical Blue (RBG-1000-10-1000) biopsy gun.
Model FNB and MBY single-use biopsy needles are exclusively intended for hollow needle biopsies of soft tissue for example from pleura cavity and associated organs, abdominal cavity and associated organs like breast, liver, prostate and kidney.
Model COX is for safe needle guidance and for taking several biopsy specimens, for example from liver, kidney, breast, thyroid, pancreas, spleen, lung and various soft tissue lesions, with only one single puncture.
Model ABG disposable automatic biopsy guns are intended for biopsies of soft tissue such as liver, kidney, prostate, breast, thyroid, pancreas, spleen, lung and various soft tissue lesions.
Model SBG disposable semiautomatic biopsy guns are intended for biopsies of soft tissue such as liver, kidney, prostate, breast, thyroid, pancreas, spleen, lung and various soft tissue lesions.
Model Moller Medical Blue RBG is a reusable, automatic biopsy gun that is intended exclusively for use with DNG-1020 / full-sCore® DNG-2020 disposable needles for core needle biopsies of soft tissue such as liver, kidney, prostate, breast, thyroid, pancreas, spleen, lung and various soft tissue lesions.
When used for breast biopsy, the product is for diagnosis only. The extent of histological 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 histological 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 of using standard surgical procedures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162588: Möller Medical Biopsy Needles and Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162588
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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