# K142080: Non-Sterile Ors Warning Drapes/Slush+Warmer Disc-Drape/Slush+Warmer Palte-Drape /Fluid Warmer Drape,Skirted

- Pathway: 510(k) (Special)
- Applicant: Ecolab, Inc.
- Decided: Aug 28, 2014 after 28 days
- Product code: LHC (Warmer, Irrigation Solution)
- Device class: 1
- Regulation: 21 CFR 890.5950
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K021288 (2002). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021288: ORS-1000LD, O.R. Solutions, Inc. (2002) Summary page 5.
- K023282: ORS-3000LD, O.R. Solutions, Inc. (2002) Summary page 5.

## Recalls of this device
- Aug 25, 2015 · Class II · Z-0191-2016: Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
- Aug 25, 2015 · Class II · Z-0184-2016: Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
- Aug 25, 2015 · Class II · Z-0185-2016: Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
- Aug 25, 2015 · Class II · Z-0189-2016: Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
- Aug 25, 2015 · Class II · Z-0186-2016: Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
- Aug 25, 2015 · Class II · Z-0187-2016: Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
- Aug 25, 2015 · Class II · Z-0188-2016: Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
- Aug 25, 2015 · Class II · Z-0190-2016: Custom surgical kits contain a component (ORS fluid warming and slush drapes) that was recalled due to compromised package integrity potentially affecting sterility assurance.
- Aug 18, 2015 · Class II · Z-2793-2015: The sterile packaging may contain small (less than 250 microns wide) channels in the seal of the pouch. If channels are present, the package integrity is compromised and there is a remote chance that 

## Indications for use
The ORS drape is a single-use equipment cover intended for use during various surgeries where warm irrigation, slush and/or cold solution is required. The following models are included: ORS-100N, ORS-300N, ORS-301N, ORS-320N, ORS-321N, ORS-330N and ORS-188231N.

Source page: https://510kreport.com/device/K142080
Methodology: https://510kreport.com/methodology