# K023282: ORS-3000LD

- Pathway: 510(k) (Traditional)
- Applicant: O.R. Solutions, Inc.
- Decided: Nov 13, 2002 after 43 days
- Product code: LHC (Warmer, Irrigation Solution)
- Device class: 1
- Regulation: 21 CFR 890.5950
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K152522: ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes (2016), 0 descendants of its own
- K142080: Non-Sterile Ors Warning Drapes/Slush+Warmer Disc-Drape/Slush+Warmer Palte-Drape /Fluid Warmer Drape,Skirted (2014), 0 descendants of its own

## Recalls of this device
- 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-3000LD is an equipment cover for the ORS-1075LD Hush-Slush® machine. This is a single use product supplied sterile. This device is intended for use during various surgeries where slush and/or cold solution is required.

Source page: https://510kreport.com/device/K023282
Methodology: https://510kreport.com/methodology