510(k) · Cleared
Recalled · Class I · 2026MD Tech Biopsy Set for Bone and Bone Marrow
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Device Technologies, Inc. · KNW Instrument, Biopsy
Cleared on Feb 3, 1998 as substantially equivalent to K961959 (Medical Device Technologies, Inc., 1996) and 3 other predicates after a 14-day review. Its family tree reaches back 2 generations to 1989. 1 of the 41 devices in its family, counting itself, has a Class I recall. 34 later devices descend from it. It has been recalled 12 times, including 3 Class I recalls.
- Decided
- Feb 3, 1998
- Review
- 14 days
- Class
- Class II
- Product code
- KNW
- Recalls
- 12 (3 Class I)
- Predicates
- 4
Its longest line of descent runs back 2 generations to K890925 (1989). 6 ancestors in all. 34 later devices descend from it, 5 citing it directly. 1 of the 41 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK890925 Manan Bone Marrow Biopsy NeedleManan Medical Products, Inc. · 1989 · Recalled
- 1 generation backK961959 MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1996
- This deviceK980196 MD Tech Biopsy Set for Bone and Bone MarrowMedical Device Technologies, Inc. · 1998
- Descendant · cites it directly · 18 of its ownK051506 Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt…Sterylab S.R.L. · 2005
- Descendant · cites it directly · 14 of its ownK062833 Powered EZ-IO Bone Marrow Aspiration SystemVidacare Corporation · 2006
- Descendant · cites it directly · 14 of its ownK043523 Interv Brand Snarelok Bone Marrow Biopsy NeedleMedical Device Technologies, Inc. · 2005
- Descendant · 2 generations on · 12 of its ownK131157 Ranfac Bone Marrow Aspiration NeedleRanfac, Corp. · 2013
- Descendant · 2 generations on · 7 of its ownK072045 Oncontrol Bone Marrow Biopsy SystemVidacare Corporation · 2007
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K051506Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft…Sterylab S.R.L. · 2005 · cites it directly18descendants
- K062833Powered EZ-IO Bone Marrow Aspiration SystemVidacare Corporation · 2006 · cites it directly14descendants
- K043523Interv Brand Snarelok Bone Marrow Biopsy NeedleMedical Device Technologies, Inc. · 2005 · cites it directly14descendants
- K131157Ranfac Bone Marrow Aspiration NeedleRanfac, Corp. · 2013 · 2 generations on12descendants
- K072045Oncontrol Bone Marrow Biopsy SystemVidacare Corporation · 2007 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K890925 | Manan Bone Marrow Biopsy Needle | Manan Medical Products, Inc. | 1989 | 7 |
| −1 | K961959 | MD Tech Biopsy Set for Bone and Bone Marrow | Medical Device Technologies, Inc. | 1996 | — |
| 0 (this device) | K980196 | MD Tech Biopsy Set for Bone and Bone Marrow | Medical Device Technologies, Inc. | 1998 | — |
| +1 | K051506 | Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut… | Sterylab S.R.L. | 2005 | — |
| +1 | K062833 | Powered EZ-IO Bone Marrow Aspiration System | Vidacare Corporation | 2006 | — |
| +1 | K043523 | Interv Brand Snarelok Bone Marrow Biopsy Needle | Medical Device Technologies, Inc. | 2005 | — |
| +2 | K131157 | Ranfac Bone Marrow Aspiration Needle | Ranfac, Corp. | 2013 | — |
| +2 | K072045 | Oncontrol Bone Marrow Biopsy System | Vidacare Corporation | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1994 | 2 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (4)
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 | Decided |
|---|---|---|---|
| * | K961959 | MD Tech Biopsy Set for Bone and Bone MarrowSummary page 1…sy Set for Bone 2o Lors Trarree” Bone and/or bone marrow aspiration/biopsy needles Needle, Biopsy, Cardiovascular, No. 79DWO Product Name $10(k) No. Bone Biopsy Needles K961959 Bone Marrow Biopsy K890925 Bone Biopsy Needle K902177 Pediatric Bone Marrow Needle K962001 These devices are intended for the p… | 1996 |
| * | K890925 | Manan Bone Marrow Biopsy NeedleSummary page 1…rree” Bone and/or bone marrow aspiration/biopsy needles Needle, Biopsy, Cardiovascular, No. 79DWO Product Name $10(k) No. Bone Biopsy Needles K961959 Bone Marrow Biopsy K890925 Bone Biopsy Needle K902177 Pediatric Bone Marrow Needle K962001 These devices are intended for the purpose of harvesting bone a… | 1989 |
| * | K902177 | Manan Bone Biopsy NeedleSummary page 1…ow aspiration/biopsy needles Needle, Biopsy, Cardiovascular, No. 79DWO Product Name $10(k) No. Bone Biopsy Needles K961959 Bone Marrow Biopsy K890925 Bone Biopsy Needle K902177 Pediatric Bone Marrow Needle K962001 These devices are intended for the purpose of harvesting bone and/or bone marrow specimens… | 1990 |
| * | K962001 | Manan Pediatric Bone Marrow Access NeedleSummary page 1…iopsy, Cardiovascular, No. 79DWO Product Name $10(k) No. Bone Biopsy Needles K961959 Bone Marrow Biopsy K890925 Bone Biopsy Needle K902177 Pediatric Bone Marrow Needle K962001 These devices are intended for the purpose of harvesting bone and/or bone marrow specimens. They are inserted percutaneously, ad… | 1997 |
What descends from it? (34)
See all 345 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051506 | Mielo-Can, Best-Lisas, Ben - Bone Biopsy. Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft… | 2005 | 18 |
| K062833 | Powered EZ-IO Bone Marrow Aspiration System | 2006 | 14 |
| K043523 | Interv Brand Snarelok Bone Marrow Biopsy Needle | 2005 | 14 |
| K162588 | Möller Medical Biopsy Needles and Systems | 2017 | 1 |
| K180807 | Celling Aspiration Needle | 2018 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 1, 2026 | Class I | Z-2706-2026 | Material/Component Contamination | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. |
| Jun 1, 2026 | Class I | Z-2709-2026 | Material/Component Contamination | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. |
| Jun 1, 2026 | Class I | Z-2707-2026 | Material/Component Contamination | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. |
| Jan 18, 2017 | Class II | Z-1195-2017 | Equipment maintenance | The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray. |
| Jan 18, 2017 | Class II | Z-1196-2017 | Equipment maintenance | The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray. |
| Jan 18, 2017 | Class II | Z-1194-2017 | Equipment maintenance | The recalling firm received a complaint from one of their customers of a potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray. |
| Jun 18, 2015 | Class II | Z-2189-2015 | Packaging process control | Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray. |
| Sep 1, 2009 | Not classified | Z-2019-2010 | Other | Medical Device Technologies doing business as Angiotech has conducted a recall on Angiotech Breast Localization Needles, Soft Tissue Biopsy Needles, Vascular Access Needles, Bone Biopsy Needles, Access Needles, Galactography Kit… |
| Jul 16, 2008 | Not classified | Z-0451-2009 | Other | Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray. |
| Jul 16, 2008 | Not classified | Z-0450-2009 | Other | Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray. |
| Jul 16, 2008 | Not classified | Z-0452-2009 | Other | Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray. |
| Jul 16, 2008 | Not classified | Z-0453-2009 | Other | Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray. |
The 5 latest of 12 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 7.3 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K051506 (Sterylab S.R.L., 2005) has gone furthest, with 18 descendants of its own.
How does its category compare?
All KNW devicesKNW Instrument, Biopsy: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Manan™ Biopsy Set for Bone and Bone Marrow is intended for the purpose of harvesting bone and/or bone marrow specimens. They are inserted percutaneously, adjacent to the biopsy site. Access to the bone and/or bone marrow specimen(s) is achieved mechanically via cutting surfaces on the device. Harvesting of bone and/or bone marrow specimen(s) is accomplished both by mechanical and negative pressure (aspiration) which is created by attaching a syringe…
Read the full statement (127 words)
The Manan™ Biopsy Set for Bone and Bone Marrow is intended for the purpose of harvesting bone and/or bone marrow specimens. They are inserted percutaneously, adjacent to the biopsy site. Access to the bone and/or bone marrow specimen(s) is achieved mechanically via cutting surfaces on the device. Harvesting of bone and/or bone marrow specimen(s) is accomplished both by mechanical and negative pressure (aspiration) which is created by attaching a syringe to a fitting on the outer cannula of the device. Specimen(s) are contained within the outer cannula during withdrawal from the patient.
In addition to the above, the pediatric bone marrow needle is intended for the purpose of obtaining access into medullary cavities for the purposes of initiating resuscitative infusion or for aspirating marrow in pediatric patients.
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/K980196 · printed Nov 5, 2026
Cite this page
510(k) Report. “K980196: MD Tech Biopsy Set for Bone and Bone Marrow.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K980196
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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