# K863047: Flexicair

- Pathway: 510(k) (Traditional)
- Applicant: Ssi Medical Services, Inc.
- Decided: Sep 5, 1986 after 24 days
- Product code: IOQ (Bed, Flotation Therapy, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5170
- Recalls of this device: 5 (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
- K964873: Silkair Low Airloss Therapy (1997), 0 descendants of its own

## Recalls of this device
- Dec 6, 2010 · Not classified · Z-1253-2011: Due to product age and parts availability the units are being withdrawn to reduce a potential health risk to patients when bed rails are not used.
- Dec 6, 2010 · Not classified · Z-1254-2011: Due to product age and parts availability the units are being withdrawn to reduce a potential health risk to patients when bed rails are not used.
- May 12, 2009 · Not classified · Z-1875-2009: The devices may emit smoke from the blower box assembly.
- May 12, 2009 · Not classified · Z-1874-2009: The devices may emit smoke from the blower box assembly.
- Aug 27, 2003 · Not classified · Z-0058-04: Reports of patient entrapment between mattress and side-rails.

Source page: https://510kreport.com/device/K863047
Methodology: https://510kreport.com/methodology