# K961973: DHD Ace with Mask Kit

- Pathway: 510(k) (Traditional)
- Applicant: Dhd Diemolding Healthcare Div.
- Decided: Aug 15, 1996 after 87 days
- Product code: CAF (Nebulizer (Direct Patient Interface))
- Device class: 2
- Regulation: 21 CFR 868.5630
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K981167: Stealth Pilot Kit/ Stealth Spacer/Face Mask Kit (1998), 0 descendants of its own

## Recalls of this device
- Mar 31, 2021 · Class II · Z-1516-2021: The firm became aware via complaints that one lot of ACE MDI Spacers with Small Masks and one lot of Palm Cups (Large) may have incorrect shipping box labels.

Source page: https://510kreport.com/device/K961973
Methodology: https://510kreport.com/methodology