# K871447: Todd Hewitt W/Cna (Lim Broth)

- Pathway: 510(k) (Traditional)
- Applicant: Remel Co.
- Decided: May 13, 1987 after 30 days
- Product code: JSD (Culture Media, Selective Broth)
- Device class: 1
- Regulation: 21 CFR 866.2360
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K170586: Strep B Carrot Broth One-Step (2017), 0 descendants of its own
- K170481: Strep B Carrot Broth Kit (2017), 0 descendants of its own

## Recalls of this device
- Aug 14, 2023 · Class II · Z-2531-2023: On lot of Todd Hewitt Broth w/CNA (LIM) may exhibit no recovery of target organism during customer QC testing or use with patient samples

Source page: https://510kreport.com/device/K871447
Methodology: https://510kreport.com/methodology