# K851606: D-PBS, Products NO. D5652

- Pathway: 510(k) (Traditional)
- Applicant: Sigma Chemical Co.
- Decided: May 15, 1985 after 29 days
- Product code: KIT (Media And Components, Synthetic Cell And Tissue Culture)
- Device class: 1
- Regulation: 21 CFR 864.2220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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
- K102867: Iroot FS (2010), 2 descendants of its own
- K213757: Endocem MTA Premixed Regular (2023), 0 descendants of its own
- K222992: iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material (2022), 0 descendants of its own

Source page: https://510kreport.com/device/K851606
Methodology: https://510kreport.com/methodology