# K070879: Bard Malecot and Pezzer Drains

- Pathway: 510(k) (Special)
- Applicant: C.R. Bard, Inc.
- Decided: Apr 24, 2007 after 25 days
- Product code: FEW (Catheter, Malecot)
- Device class: 2
- Regulation: 21 CFR 876.5090
- 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 K910197 (1991). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910197: Hydrogel-Coated Urethral Catheters and Drains, C.R. Bard, Inc. (1991) Summary page 1.
- K910846: Bard Latex Urinary Catheters Drains- Designs Modif, C.R. Bard, Inc. (1991) Summary page 1.

## Most influential descendants
- K101900: Hakki Urinary Catheter; Size 14, 16, 18, 20, 22, 24, 26 French (2011), 1 descendant of its own
- K191512: LotusCatheter (Lotus No Balloon Catheter) (2020), 0 descendants of its own

## Indications for use
Bard malecot and pezzer drains are intended for use in the drainage of urine. The drains are inserted suprapubically into the bladder or through a nephrostomy tract.

Source page: https://510kreport.com/device/K070879
Methodology: https://510kreport.com/methodology