# K945993: Vapofil

- Pathway: 510(k) (Traditional)
- Applicant: Southmedic, Inc.
- Decided: Feb 22, 1995 after 96 days
- Product code: CAD (Vaporizer, Anesthesia, Non-Heated)
- Device class: 2
- Regulation: 21 CFR 868.5880
- Recalls of this device: 2 (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; 1 cites 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K053564: Keyed Filler Bottle Adaptor, Models 53450, 53452, 53453, 53454 (2006), 1 descendant of its own
- K110608: Sevoflurane Vaporizer Adaptor (2011), 0 descendants of its own

## Recalls of this device
- Apr 21, 2006 · Not classified · Z-1189-06: Southmedic has initiated this recall because their Japanese distributor received field reports of leaking vapofils. Leakage may cause non-toxic spills in the hospital environment, distraction of pract
- Apr 21, 2006 · Not classified · Z-1190-06: Southmedic has initiated this recall because their Japanese distributor received field reports of leaking vapofils. Leakage may cause non-toxic spills in the hospital environment, distraction of pract

Source page: https://510kreport.com/device/K945993
Methodology: https://510kreport.com/methodology