# K903054: HME-10 (TM)

- Pathway: 510(k) (Traditional)
- Applicant: Pharma Systems, Inc.
- Decided: Oct 31, 1990 after 112 days
- Product code: BYD (Condenser, Heat And Moisture (Artificial Nose))
- Device class: 1
- Regulation: 21 CFR 868.5375
- 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Feb 19, 2015 · Class III · Z-1596-2015: Outer shipping carton was marked with an incorrect expiry date, however inner product carton was labeled correctly.

Source page: https://510kreport.com/device/K903054
Methodology: https://510kreport.com/methodology