# K152522: ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes

- Pathway: 510(k) (Special)
- Applicant: Ecolab, Inc.
- Decided: Jan 15, 2016 after 134 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: 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 4.
- K023282: ORS-3000LD, O.R. Solutions, Inc. (2002) Summary page 5.

## Indications for use
The ORS-3000LD is an equipment cover for the ORS-1075LD Hush-Slush®machine. This is a single use product supplied sterile. This device is intended to be used during various surgeries where slush and/or cold solution is required. Models: ORS-130/0RS-130-16, ORS-320/ORS-320-16, ORS-321/0RS-321-16, ORS-325/0RS-325-16, 330/0RS-330-16, ORS-331/0RS-331-16 The ORS-1000LD Leak Detection Drape is an equipment cover for the ORS-2000LD Solution Warmer. This is a single use product supplied sterile. This device is intended for use during various surgeries where warm irrigation solution is required. Models: ORS-100, ORS-110, ORS-300, ORS-301

Source page: https://510kreport.com/device/K152522
Methodology: https://510kreport.com/methodology