510(k) Report

510(k) · Cleared

Cleared

ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes

K152522510(k) SpecialCleared Jan 15, 2016134-day reviewClass I21 CFR 890.5950

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ecolab, Inc. · LHC Warmer, Irrigation Solution

Cleared on Jan 15, 2016 as substantially equivalent to K021288 (O.R. Solutions, Inc., 2002) and 1 other predicate after a 134-day review. Its family tree reaches back 1 generation to 2002.

Decided
Jan 15, 2016
Review
134 days
Class
Class I
Product code
LHC
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K021288 (2002). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestorK021288 · ORS-1000LD · O.R. Solutions, Inc. · 2002 · recalled2000200520102015
Other ancestors, by generation 1 generation back: 1 other ancestor K021288 · ORS-1000LD · O.R. Solutions, Inc. · 2002 · recalled0
  1. Root · 1 generation backK021288 ORS-1000LDO.R. Solutions, Inc. · 2002 · Recalled
  2. This deviceK152522 ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming DrapesEcolab, Inc. · 2016
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K021288ORS-1000LDO.R. Solutions, Inc.20021
0 (this device)K152522ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming DrapesEcolab, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210
FIG. 1 — Lineage of K152522, 2002–2016Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in LHC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K021288ORS-1000LD
Summary page 4
…ospital Classification Regulation: Pre-amendment Performance Standards: No Recognized Consensus Standards Predicate Device: K021288: ORS-1000LD Covers ORS-100, ORS-110, ORS-300, and ORS-301…
O.R. Solutions, Inc.20021
*K023282ORS-3000LD
Summary page 5
…5-1 Ecolab Inc. ORS Fluid Warming and Slush Drapes K023282: ORS-3000LD Covers ORS-130, ORS-320, ORS-321, ORS-325, ORS-…
O.R. Solutions, Inc.20021

Also cleared against K021288: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 2 of the 2 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K021288.

How does its category compare?

All LHC devices

LHC Warmer, Irrigation Solution: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · LHC

2in 2016

2008: 12009: 12014: 22015: 12016: 2
2007high 2 (2014) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LHC

Too few LHC 510(k)s in any year since 2007 to give a median.

Recalls per year · LHC

8in 2015

2015: 8
2007high 8 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LHC

6in 2025

2007: 32008: 52009: 22010: 12011: 22012: 52013: 22014: 42015: 132016: 692017: 332018: 302019: 82020: 42021: 52022: 12024: 52025: 6
2007high 69 (2016) · low 0 (2023)2025

MAUDE reports naming product code LHC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—03
20081—05
20091—02
20100—01
20110—02
20120—05
20130—02
20142—04
20151—813
20162—069
20170—033
20180—030
20190—08
20200—04
20210—05
20220—01
20230—00
20240—05
20250—06
20260—0—

What is it indicated for?

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

Indications for use as stated in the FDA summary.

Also cleared against K021288

2 other devices cite the same predicate.

  • K142173Non-Sterile Ors-400N Scope Pillow Warmer DrapeEcolab, Inc. · 2014
  • K142080Non-Sterile Ors Warning Drapes/Slush+Warmer Disc-Drape/Slush+Warmer Palte-Drape /Fluid Warmer Drape,SkirtedEcolab, Inc. · 20149 recalls

More from Ecolab, Inc.

7 FDA decisions under this applicant name. See the company

  • K182164Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower…Ecolab, Inc. · 2019
  • K173164Ecolab POU Water FilterEcolab, Inc. · 2018
  • K150190IntraTemp Solution WarmerEcolab, Inc. · 2015
  • K142173Non-Sterile Ors-400N Scope Pillow Warmer DrapeEcolab, Inc. · 2014
  • K142080Non-Sterile Ors Warning Drapes/Slush+Warmer Disc-Drape/Slush+Warmer Palte-Drape /Fluid Warmer Drape,SkirtedEcolab, Inc. · 20149 recalls

Recent decisions in LHC

The LHC category page

  • K153713Getinge Series Warming CabinetGetinge Sourcing, LLC · 2016
  • K150190IntraTemp Solution WarmerEcolab, Inc. · 2015
  • K142173Non-Sterile Ors-400N Scope Pillow Warmer DrapeEcolab, Inc. · 2014
  • K142080Non-Sterile Ors Warning Drapes/Slush+Warmer Disc-Drape/Slush+Warmer Palte-Drape /Fluid Warmer Drape,SkirtedEcolab, Inc. · 20149 recalls
  • K083417Intratemp Solution WarmerC Change Surgical, LLC · 2009

https://510kreport.com/device/K152522 · printed Nov 6, 2026

Cite this page

510(k) Report. “K152522: ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152522

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026