# K970295: Flexicair Exlipse Plus

- Pathway: 510(k) (Traditional)
- Applicant: Hill-Rom, Inc.
- Decided: May 16, 1997 after 109 days
- Product code: IOQ (Bed, Flotation Therapy, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5170
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K951001 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951001: Flexicair Exlipse, Hill-Rom, Inc. (1995) Summary page 1.

## Cited in the summary but kept off the family tree
- K930673: Premium, Kinetic Concepts, Inc. (1993). Our OCR of the scanned summary read K930673, FDA’s number for Premium (Kinetic Concepts, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “FIRST STEP”. Kept off the family tree. Summary page 1.

## Indications for use
The standard FLEXICAIR® ECLIPSE™, the FLEXICAIR® ECLIPSE™ PLUS and the FLEXICAIR® ECLIPSE™ ULTRA Mattress Replacements are intended to provide low-airloss therapy for different ranges of patient weights. The standard FLEXICAIR® ECLIPSE™ used on general Med-Surg or specialty beds covers all patient weights up to 300 Ibs. The FLEXICAIR® ECLIPSE™ PLUS covers patient weights from 301 Ibs to 450 Ibs on Hill-Rom Century, Centra and Advance 1000 bed frames and on the Stryker MPS bed frame. The FLEXICAIR® ECLIPSE™ ULTRA covers patient weights from 451 to 800 Ibs on the Hill-Rom Magnum/Magnum II bed frames.

Source page: https://510kreport.com/device/K970295
Methodology: https://510kreport.com/methodology