510(k) · Cleared
Recalled · Class II · 2015ORS-1000LD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
O.R. Solutions, Inc. · LHC Warmer, Irrigation Solution
Cleared on Jun 27, 2002 after a 65-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 3 later devices descend from it. It has been recalled once.
- Decided
- Jun 27, 2002
- Review
- 65 days
- Class
- Class I
- Product code
- LHC
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK021288 ORS-1000LDO.R. Solutions, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK152522 ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming DrapesEcolab, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK142173 Non-Sterile Ors-400N Scope Pillow Warmer DrapeEcolab, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK142080 Non-Sterile Ors Warning Drapes/Slush+Warmer Disc-Drape/Slush+Warmer…Ecolab, Inc. · 2014 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K152522ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming DrapesEcolab, Inc. · 2016 · cites it directly0descendants
- K142173Non-Sterile Ors-400N Scope Pillow Warmer DrapeEcolab, Inc. · 2014 · cites it directly0descendants
- K142080Non-Sterile Ors Warning Drapes/Slush+Warmer Disc-Drape/Slush+Warmer Palte-Drape /Fluid…Ecolab, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021288 | ORS-1000LD | O.R. Solutions, Inc. | 2002 | — |
| +1 | K152522 | ORS-3000LD Slush Drapes, ORS-1000LD Fluid Warming Drapes | Ecolab, Inc. | 2016 | — |
| +1 | K142173 | Non-Sterile Ors-400N Scope Pillow Warmer Drape | Ecolab, Inc. | 2014 | — |
| +1 | K142080 | Non-Sterile Ors Warning Drapes/Slush+Warmer Disc-Drape/Slush+Warmer… | Ecolab, Inc. | 2014 | 9 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K152522 (Ecolab, Inc., 2016) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LHC devicesLHC Warmer, Irrigation Solution: FDA decisions, review times, recalls and adverse event reports over 20 years.
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-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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K021288 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021288: ORS-1000LD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021288
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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