# K901442: Baxter D & C Tray

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Jul 26, 1990 after 121 days
- Product code: HCY (Curette, Uterine)
- Device class: 1
- Regulation: 21 CFR 884.4530
- 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.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K972013: National Medical Healthcare Custom OB/Gyn Kits, Trays, or Packs (1997), 0 descendants of its own

## Recalls of this device
- Jan 7, 2016 · Class II · Z-1402-2016: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.

Source page: https://510kreport.com/device/K901442
Methodology: https://510kreport.com/methodology