# K980226: Manan Pro-Mag Automatic Biopsy System

- Pathway: 510(k) (Traditional)
- Applicant: Medical Device Technologies, Inc.
- Decided: Feb 18, 1998 after 27 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K895897 (1989). 3 ancestors in all.
22 later devices descend from it; 3 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)
- K895897: Manan Prostatic Biopsy Needle, Manan Medical Products, Inc. (1989) Summary page 1.
- K914874: Manan Pro-Mag Automatic Biopsy Device, Manan Medical Products, Inc. (1992) Summary page 1.
- K921418: Ultra-Core Biopsy Needles, Medical Device Technologies, Inc. (1992) 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

## Recalls of this device
- Sep 1, 2009 · Not classified · Z-2016-2010: 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

## Indications for use
The Manan™ Pro-Mag Automatic Biopsy System 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/K980226
Methodology: https://510kreport.com/methodology