# K133948: Bard (R) Monopty (R) Disposable Core Biopsy Instrument, Bard (R) Max-Core (R) Disposable Core Instrument

- Pathway: 510(k) (Special)
- Applicant: Bard Peripheral Vascular, Inc.
- Decided: Feb 21, 2014 after 60 days
- Product code: KNW (Instrument, Biopsy)
- Device class: 2
- Regulation: 21 CFR 876.1075
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K922939 (1993). 1 ancestor in all.
27 later devices descend from it; 13 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K922939: Bard Monopty Disposable Core Biopsy Isnt. W/ Cent., C.R. Bard, Inc. (1993) Summary page 1.

## Most influential descendants
- K141552: Achieve Programmable Auomated Biopsy Systems (2014), 11 descendants of its own
- K171953: Bard Mission Disposable Core Biopsy Instrument (2017), 5 descendants of its own
- K160316: SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles (2016), 4 descendants of its own
- K192101: Medone Ultra, Medextra (2020), 2 descendants of its own
- K153337: Corvocet Biopsy System (2016), 2 descendants of its own

## Recalls of this device
- Sep 30, 2024 · Class II · Z-0467-2025: Disposable biopsy instruments were potentially manufactured missing the backend notch retention feature on the needle that results in inadequate securing of the needle inside the device, which could l
- Aug 10, 2023 · Class II · Z-0027-2024: Diameter mismatch between coaxial and biopsy needle (cutting cannula) in disposable core biopsy instrument kits, where the coaxial cannula inner diameter prohibits the biopsy needle (cutting cannula) 
- Jan 14, 2021 · Class II · Z-1289-2021: Due to the Penetration Depth Switch used to select the desired penetration depth of the biopsy needle for soft tissue biopsies, detaches from the device during use.
- Oct 25, 2019 · Class II · Z-0724-2020: During the firm's review of May 2019 complaint data, a significant increase in Disposable Core Biopsy Instrument complaints were observed for Failure to Fire, Firing Problem, and Failure to Obtain Sam
- Sep 22, 2017 · Class II · Z-0044-2018: During the review of May 2017 complaint data, a significant increase in MAX-CORE Disposable Core Biopsy Instrument complaints was observed for Failure to Prime, Failure to Fire, Failure to Obtain Samp
- Apr 9, 2015 · Class II · Z-1586-2015: The firm is recalling Bard MAX-CORE Disposable Core Biopsy Instrument due to the risk of having self-activation-related issues.
- Mar 17, 2015 · Class II · Z-1447-2015: Bard Peripheral Vascular is recalling the Bard Monopty Disposable Core Biopsy Instruments and Kits because they may be at risk of having activation-related issues.

## Indications for use
The core needle biopsy device is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, spleen, lymph nodes and various soft tissue tumors. It is not intended for use in bone.

Source page: https://510kreport.com/device/K133948
Methodology: https://510kreport.com/methodology