# K962969: Medical Device Technologies, Inc.Ultra

- Pathway: 510(k) (Traditional)
- Applicant: Medical Device Technologies, Inc.
- Decided: Dec 6, 1996 after 128 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: 1 generation back to K871390 (1987). 2 ancestors in all.
27 later devices descend from it; 4 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914874: Manan Pro-Mag Automatic Biopsy Device, Manan Medical Products, Inc. (1992) Summary page 1.
- K871390: Bard Biopty Biopsy System, C.R. Bard, Inc. (1987) Summary page 1.

## Most influential descendants
- K982085: Medical Device Technologies, Inc. Tru-Core Disposale Semi-Automatic Biopdy Instrument (1998), 25 descendants of its own
- K982960: Meical Device Technologies, Inc. Tru-Core Disposable Automatic Biopsy Instrument (1998), 24 descendants of its own
- K990839: Tru-Core I Reusable Biopsy Instrument (1999), 20 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
- K131157: Ranfac Bone Marrow Aspiration Needle (2013), 12 descendants of its own

## Indications for use
The Ultra™ Biopsy Device is used to obtain 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/K962969
Methodology: https://510kreport.com/methodology