# K990839: Tru-Core I Reusable Biopsy Instrument

- Pathway: 510(k) (Traditional)
- Applicant: Medical Device Technologies, Inc.
- Decided: May 20, 1999 after 66 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K871390 (1987). 5 ancestors in all.
20 later devices descend from it; 2 cite it directly.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K962969: Medical Device Technologies, Inc.Ultra, Medical Device Technologies, Inc. (1996) Summary page 1.
- K982960: Meical Device Technologies, Inc. Tru-Core Disposable Automatic Biopsy Instrument, Medical Device Technologies, Inc. (1998) 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
- K131157: Ranfac Bone Marrow Aspiration Needle (2013), 12 descendants of its own
- K140991: Ranfac Aspiration Needle with Adjustable Guide (2014), 5 descendants of its own
- K150563: Marrow Cellution Bone Marrow Aspiration Needle (2015), 4 descendants of its own
- K070759: Powered EZ-IO Pediatric Bone Marrow Aspiration System (2007), 3 descendants of its own

## Indications for use
The Tru-Core™ I Reusable Biopsy Instrument is intended for use in obtaining multiple core samples from soft tissue such as the liver, kidney, prostate, breast, and various soft tissue lesions. It is not intended for bone.

Source page: https://510kreport.com/device/K990839
Methodology: https://510kreport.com/methodology