# K980196: MD Tech Biopsy Set for Bone and Bone Marrow

- Pathway: 510(k) (Traditional)
- Applicant: Medical Device Technologies, Inc.
- Decided: Feb 3, 1998 after 14 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 12 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K890925 (1989). 6 ancestors in all.
34 later devices descend from it; 5 cite it directly.
1 of 41 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961959: MD Tech Biopsy Set for Bone and Bone Marrow, Medical Device Technologies, Inc. (1996) Summary page 1.
- K890925: Manan Bone Marrow Biopsy Needle, Manan Medical Products, Inc. (1989) Summary page 1.
- K902177: Manan Bone Biopsy Needle, Manan Medical Products, Inc. (1990) Summary page 1.
- K962001: Manan Pediatric Bone Marrow Access Needle, Manan Medical Products, Inc. (1997) Summary page 1.

## Most influential descendants
- K051506: Mielo-Can, Best-Lisas, Ben - Bone Biopsy.  Fast-Cut, Colt, Spring-Cut, Bio-Cut - Soft Tissue Biopsy (2005), 18 descendants of its own
- K062833: Powered EZ-IO Bone Marrow Aspiration System (2006), 14 descendants of its own
- K043523: Interv Brand Snarelok Bone Marrow Biopsy Needle (2005), 14 descendants of its own
- K131157: Ranfac Bone Marrow Aspiration Needle (2013), 12 descendants of its own
- K072045: Oncontrol Bone Marrow Biopsy System (2007), 7 descendants of its own

## Recalls of this device
- Jun 1, 2026 · Class I · Z-2706-2026: 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: 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: 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: 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 t
- Jan 18, 2017 · Class II · Z-1196-2017: 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 t
- Jan 18, 2017 · Class II · Z-1194-2017: 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 t
- Jun 18, 2015 · Class II · Z-2189-2015: 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: 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, Acces
- Jul 16, 2008 · Not classified · Z-0451-2009: Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray.
- Jul 16, 2008 · Not classified · Z-0450-2009: Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray.
- Jul 16, 2008 · Not classified · Z-0452-2009: Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray.
- Jul 16, 2008 · Not classified · Z-0453-2009: Product packaging for Bone Biopsy trays/blisters may have a hole in the formed tray.

## Indications for use
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.

Source page: https://510kreport.com/device/K980196
Methodology: https://510kreport.com/methodology