510(k) · Cleared
Recalled · Class II · 2015Non-Sterile Ors Warning Drapes/Slush+Warmer Disc-Drape/Slush+Warmer Palte-Drape /Fluid Warmer Drape,Skirted
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ecolab, Inc. · LHC Warmer, Irrigation Solution
Cleared on Aug 28, 2014 as substantially equivalent to K021288 (O.R. Solutions, Inc., 2002) and 1 other predicate after a 28-day review. Its family tree reaches back 1 generation to 2002. It has been recalled 9 times.
- Decided
- Aug 28, 2014
- Review
- 28 days
- Class
- Class I
- Product code
- LHC
- Recalls
- 9
- 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.
- Root · 1 generation backK021288 ORS-1000LDO.R. Solutions, Inc. · 2002 · Recalled
- This deviceK142080 Non-Sterile Ors Warning Drapes/Slush+Warmer Disc-Drape/Slush+Warmer…Ecolab, Inc. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021288 | ORS-1000LD | O.R. Solutions, Inc. | 2002 | 1 |
| 0 (this device) | K142080 | Non-Sterile Ors Warning Drapes/Slush+Warmer Disc-Drape/Slush+Warmer… | Ecolab, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K021288 | ORS-1000LDSummary page 5…amendment Performance Standards: No Recognized Consensus Standards Predicate Device: ORS-1000LD [covers ORS-100, ORS-300, ORS-301, ORS-188231] cleared on 06/27/2002 via K021288 and ORS-3000LD [covers ORS-320, ORS-321. ORS-330] cleared 11/13/2002 via K023282 Ecolab Inc. Non-Sterile ORS Warm… | 2002 |
| * | K023282 | ORS-3000LDSummary page 5…ce: ORS-1000LD [covers ORS-100, ORS-300, ORS-301, ORS-188231] cleared on 06/27/2002 via K021288 and ORS-3000LD [covers ORS-320, ORS-321. ORS-330] cleared 11/13/2002 via K023282 Ecolab Inc. Non-Sterile ORS Warming and Slush Drapes Device Description The Non-Sterile ORS Warming and Slush D… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 25, 2015 | Class II | Z-0191-2016 | Packaging | 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 | Packaging | 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 | Packaging | 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 | Packaging | 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 | Packaging | 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 | Packaging | 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 | Packaging | 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 | Packaging | 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 | Package design/selection | 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 a non-sterile drape may be used during… |
The 5 latest of 9 recalls; the web page lists all.
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 devicesLHC Warmer, Irrigation Solution: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · LHC
2in 2016
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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LHC
6in 2025
MAUDE reports naming product code LHC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 3 |
| 2008 | 1 | — | 0 | 5 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 5 |
| 2013 | 0 | — | 0 | 2 |
| 2014 | 2 | — | 0 | 4 |
| 2015 | 1 | — | 8 | 13 |
| 2016 | 2 | — | 0 | 69 |
| 2017 | 0 | — | 0 | 33 |
| 2018 | 0 | — | 0 | 30 |
| 2019 | 0 | — | 0 | 8 |
| 2020 | 0 | — | 0 | 4 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K142080 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142080: Non-Sterile Ors Warning Drapes/Slush+Warmer Disc-Drape/Slush+Warmer Palte-Drape /Fluid Warmer Drape,Skirted.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142080
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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