# K142173: Non-Sterile Ors-400N Scope Pillow Warmer Drape

- Pathway: 510(k) (Traditional)
- Applicant: Ecolab, Inc.
- Decided: Dec 30, 2014 after 145 days
- Product code: LHC (Warmer, Irrigation Solution)
- Device class: 1
- Regulation: 21 CFR 890.5950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K990334 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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 4.
- K051979: Ors Model 6000 Endoscope Holder, O.R. Solutions, Inc. (2005) Summary page 4.

## Indications for use
The ORS pillow drape is a single-use disposable device intended for use as an accessory for ORS Solution Warmers which is designed to hold the optical end of various endoscopes above the warm solution to prevent fogging or wetting of the scope eyepiece. The following model(s) are included: ORS-400 and ORS-400N

Source page: https://510kreport.com/device/K142173
Methodology: https://510kreport.com/methodology