# K024240: BD Vacutainer Plus Plastic Urine C&S Preservayive Tubes and Kits

- Pathway: 510(k) (Traditional)
- Applicant: Bd
- Decided: Mar 26, 2003 after 93 days
- Product code: JSM (Culture Media, Non-Propagating Transport)
- Device class: 1
- Regulation: 21 CFR 866.2390
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
5 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K790336: Union Carbide Corp. Computer Interface, Union Carbide Corp. (1979). Our reading of the summary gave K790336, FDA’s number for Union Carbide Corp. Computer Interface (Union Carbide Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “BD Vacutainer™ Brand Glass Urine C&S Preservative Tubes and Kits”. Kept off the family tree. Summary page 2.

## Most influential descendants
- K180052: UriSwab-Urine Collection, Transport and Preservation System (2018), 2 descendants of its own
- K232565: UriSponge™ (2024), 0 descendants of its own
- K220739: Disposable Urine Collection Tube (2022), 0 descendants of its own
- K163436: Greiner Vacuette Urine Count and Culture, Mannitol tube (2017), 0 descendants of its own
- K070062: Coproset Salmonella and Shigella, Uriset Preservative Tubes and Swab Set General Use (2007), 0 descendants of its own

## Recalls of this device
- Oct 12, 2009 · Not classified · Z-1023-2010: A small amount of discoloration was noted on Towelettes included in BD Vacutainer Urine collection kits. The entire kit components retain sterile interiors and no viable growth was detected on the tow
- Oct 12, 2009 · Not classified · Z-1024-2010: A small amount of discoloration was noted on Towelettes included in BD Vacutainer Urine collection kits. The entire kit components retain sterile interiors and no viable growth was detected on the tow
- Oct 12, 2009 · Not classified · Z-1025-2010: A small amount of discoloration was noted on Towelettes included in BD Vacutainer Urine collection kits. The entire kit components retain sterile interiors and no viable growth was detected on the tow

## Indications for use
The BD Vacutainer™PLUS Plastic Urine C&S Preservative Tubes and Kits are intended for the collection and transport of urine samples for culture and sensitivity testing of bacteria. The BD Vacutainer™PLUS Plastic Urine C&S Preservative Tube is filled with lyophilized urine maintenance formula and evacuated to draw approximately 4 - 10 mL (depending on the tube size) of urine. The lyophilized urine maintenance formula can maintain the bacterial population in the urine specimen for a period of 48 hours at room temperature levels comparable to those urine specimens without additive, held under refrigeration for the same period of time.

Source page: https://510kreport.com/device/K024240
Methodology: https://510kreport.com/methodology