# K961959: MD Tech Biopsy Set for Bone and Bone Marrow

- Pathway: 510(k) (Traditional)
- Applicant: Medical Device Technologies, Inc.
- Decided: Jul 19, 1996 after 60 days
- Product code: GAA (Needle, Aspiration And Injection, Disposable)
- Device class: 1
- Regulation: 21 CFR 878.4800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K890925 (1989). 3 ancestors in all.
35 later devices descend from it; 1 cites it directly.
1 of 39 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K890925: Manan Bone Marrow Biopsy Needle, Manan Medical Products, Inc. (1989) Summary page 1.
- K940025: Manan Bone Marrow Harvest Needles, Manan Medical Products, Inc. (1994). Our OCR of the scanned summary read K940023, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Bone Marrow Harvest Needle”.
- K945109: Monoject Bone Marrow Biopsy Trays, Sherwood Medical Co. (1994) Summary page 1.

## Cited in the summary but kept off the family tree
- K930732: Delfia Cortisol Kit, Wallac OY (1993). Our OCR of the scanned summary read K930732, FDA’s number for Delfia Cortisol Kit (Wallac OY). Its FDA name has none of the distinctive words the summary uses for the device it names, “Super Core Biopsy Needle”. Kept off the family tree. Summary page 1.

## Most influential descendants
- K980196: MD Tech Biopsy Set for Bone and Bone Marrow (1998), 34 descendants of its own
- 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

## Indications for use
The MD Tech Biopsy-Set is intended for the purpose of harvesting bone and/or bone marrow specimens.

Source page: https://510kreport.com/device/K961959
Methodology: https://510kreport.com/methodology